Class IIOngoingZ-1126-2025

Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT

Cardinal Health 200, LLCWaukegan, IL, United StatesReported Feb 19, 2025 · 1 year ago

By Taylor Coteus

Legal News Analyst · Feb 19, 2025

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5) KIT,DIEP FLAP , Catalog Number:PB23DFCM7; 6) KIT,DIEP FLAP , Catalog Number:PB23DFCMA; 7) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ10; 8) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ11; 9) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ12; 10) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ13; 11) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ14; 12) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ15; 13) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ16; 14) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ17; 15) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ18; 16) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ19; 17) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ20; 18) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU1; 19) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU2; 20) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU3; 21) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU4; 22) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU5; 23) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU6; 24) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU7; 25) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU8; 26) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU9; 27) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUA; 28) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUB; 29) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUC; 30) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUD; 31) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUE; 32) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUF; 33) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU2; 34) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU3; 35) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU4; 36) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU5; 37) KIT, HEAD AND NECK , Catalog Number:PG40HNAJUC; 38) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ10; 39) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ11; 40) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ12; 41) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ13; 42) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ14; 43) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ15; 44) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ16; 45) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ17; 46) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ18; 47) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ19; 48) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ20; 49) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ21; 50) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ22; 51) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ23; 52) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ24; 53) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU4; 54) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU5; 55) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU6; 56) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU7; 57) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU8; 58) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU9; 59) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJUE; 60) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJUF; 61) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME1; 62) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME2; 63) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME3; 64) KIT, WILLIAMS SPINE , Cat

Lot / code information

UDI: 10888439587050 (each) 50888439587058 (case)
Lot #: J37U13 ; 2) PB23DFCM4
UDI: 10888439601053 (each) 50888439601051 (case)
Lot #: J37U14 ; 3) PB23DFCM5
UDI: 10888439641790 (each) 50888439641798 (case)
Lot #: J46C08 ; 4) PB23DFCM6
UDI: 10888439836172 (each) 50888439836170 (case)
Lot #: J6050A ; 5) PB23DFCM7
UDI: 10888439853087 (each) 50888439853085 (case)
Lot #: J7704J ; 6) PB23DFCMA

Additional code information

; 329) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: J9602U ; 330) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 5135998 ; 331) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 5140357 ; 332) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 5664108 ; 333) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 5664107 ; 334) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 5664108 ; 335) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 5841390 ; 336) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 5533340 ; 337) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 5970336 ; 338) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 6022136 ; 339) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 6025793 ; 340) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 202109016-KSH ; 341) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 6264572 ; 342) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 6264573 ; 343) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 6702034 ; 344) SBA69MFSUC, UDI-DI:10197106513606 (each) 50197106513604 (case), Lot Number: 7280116 ; 345) SBA69MFSUC, UDI-DI:10197106513606 (each) 50197106513604 (case), Lot Number: 7320243 ; 346) SBA69MFSUC, UDI-DI:10197106513606 (each) 50197106513604 (case), Lot Number: 7331347 ; 347) SBA69MFSUC, UDI-DI:10197106513606 (each) 50197106513604 (case), Lot Number: 7332920 ; 348) SBA69MFSUC, UDI-DI:10197106513606 (each) 50197106513604 (case), Lot Number: 7332924 ; 349) SBA69MFSUC, UDI-DI:10197106513606 (each) 50197106513604 (case), Lot Number: 7349697 ; 350) SBA69MFSUC, UDI-DI:10197106513606 (each) 50197106513604 (case), Lot Number: 7365541 ; 351) SBA69PBK10, UDI-DI:10195594584252 (each) 50195594584250 (case), Lot Number: 5664033 ; 352) SBA69PBKKD, UDI-DI:10888439676594 (each) 50888439676592 (case), Lot Number: J5678M ; 353) SBA69PBKKD, UDI-DI:10888439676594 (each) 50888439676592 (case), Lot Number: J6365X ; 354) SBA69PBKKD, UDI-DI:10888439676594 (each) 50888439676592 (case), Lot Number: J79F30 ; 355) SBA7CFPYN2, UDI-DI:10195594017668 (each) 50195594017666 (case), Lot Number: J9602W ; 356) SBA7CFPYN3, UDI-DI:10195594169565 (each) 50195594169563 (case), Lot Number: J9850M ; 357) SBA7CFPYN4, UDI-DI:10195594340896 (each) 50195594340894 (case), Lot Number: 5140385 ; 358) SBA7CFPYN5, UDI-DI:10197106173770 (each) 50197106173778 (case), Lot Number: 6702034 ; 359) SBA7CFPYN6, UDI-DI:10197106531037 (each) 50197106531035 (case), Lot Number: 7280116 ; 360) SBA7CFPYN6, UDI-DI:10197106531037 (each) 50197106531035 (case), Lot Number: 7320240 ; 361) SBA7CFPYN7, UDI-DI:10197106563182 (each) 50197106563180 (case), Lot Number: 7320242 ; 362) SBA7CFPYN8, UDI-DI:10197106799932 (each) 50197106799930 (case), Lot Number: 7331349 ; 363) SBA7CFPYNT, UDI-DI:10888439532609 (each) 50888439532607 (case), Lot Number: J46C07 ; 364) SBA7CFPYNT, UDI-DI:10888439532609 (each) 50888439532607 (case), Lot Number: J4952N ; 365) SBA7CFPYNT, UDI-DI:10888439532609 (each) 50888439532607 (case), Lot Number: J53W78 ; 366) SBA7CFPYNT, UDI-DI:10888439532609 (each) 50888439532607 (case), Lot Number: J53W80 ; 367) SBA7CFPYNT, UDI-DI:10888439532609 (each) 50888439532607 (case), Lot Number: J7963Y ; 368) SBA7CFPYNT, UDI-DI:10888439532609 (each) 50888439532607 (case), Lot Number: J7963X ; 369) SBA7CFPYNT, UDI-DI:10888439532609 (each) 50888439532607 (case), Lot Number: J84K06 ; 370) SBA7CFPYNT, UDI-DI:10888439532609 (each) 50888439532607 (case), Lot Number: J6368X ; 371) SBA7CFPYNT, UDI-DI:10888439532609 (each) 50888439532607 (case), Lot Number: J6368X ; 372) SBA7CFPYNT, UDI-DI:10888439532609 (each) 50888439532607 (case), Lot Number: 5533338 ; 373) SBA7CFPYNT, UDI-DI:10888439532609 (each) 50888439532607 (case), Lot Number: 5631076 ; 374) SBA7CFPYNT, UDI-DI:10888439532609 (each) 50888439532607 (case), Lot Number: 5664105 ; 375) SBA7CFPYNT, UDI-DI:10888439532609 (each) 50888439532607 (case), Lot Number: J6050C ; 376) SBA7CFPYNU, UDI-DI:10195594678852 (each) 50195594678850 (case), Lot Number: 5533340 ; 377) SBA7CFPYNV, UDI-DI:10195594734244 (each) 50195594734242 (case), Lot Number: 6788668 ; 378) SBA7CFPYNV, UDI-DI:10195594734244 (each) 50195594734242 (case), Lot Number: 6788671 ; 379) SBA7CFPYNV, UDI-DI:10195594734244 (each) 50195594734242 (case), Lot Number: 7005491 ; 380) SBA7CFPYNV, UDI-DI:10195594734244 (each) 50195594734242 (case), Lot Number: 7163083 ; 381) SBA7CFPYNV, UDI-DI:10195594734244 (each) 50195594734242 (case), Lot Number: 7163149 ; 382) SBA7CFPYNV, UDI-DI:10195594734244 (each) 50195594734242 (case), Lot Number: 7163035 ; 383) SBA7CFPYNV, UDI-DI:10195594734244 (each) 50195594734242 (case), Lot Number: 6133662 ; 384) SBA7CFPYNV, UDI-DI:10195594734244 (each) 50195594734242 (case), Lot Number: 6345526 ; 385) SBA7CFPYNV, UDI-DI:10195594734244 (each) 50195594734242 (case), Lot Number: 6560947 ; 386) SBA7CFPYNW, UDI-DI:10197106607817 (each) 50197106607815 (case), Lot Number: 7349699 ; 387) SBA7CFPYNW, UDI-DI:10197106607817 (each) 50197106607815 (case), Lot Number: 7280112 ; 388) SBA7CFPYNW, UDI-DI:10197106607817 (each) 50197106607815 (case), Lot Number: 7365541 ; 389) SBA7CFPYNW, UDI-DI:10197106607817 (each) 50197106607815 (case), Lot Number: 7332923 ; 390) SBA7CFPYNX, UDI-DI:10197106764459 (each) 50197106764457 (case), Lot Number: 7163105 ; 391) SBA95BMHH1, UDI-DI:10195594018535 (each) 50195594018533 (case), Lot Number: J96N38 ; 392) SBA95BMHH1, UDI-DI:10195594018535 (each) 50195594018533 (case), Lot Number: J9601R ; 393) SBA95BMHH2, UDI-DI:10195594300517 (each) 50195594300515 (case), Lot Number: 5324048 ; 394) SBA95BMHH2, UDI-DI:10195594300517 (each) 50195594300515 (case), Lot Number: 5138269 ; 395) SBA95BMHH3, UDI-DI:10195594361716 (each) 50195594361714 (case), Lot Number: 5138226 ; 396) SBA95BMHH3, UDI-DI:10195594361716 (each) 50195594361714 (case), Lot Number: 5508047 ; 397) SBA95BMHH4, UDI-DI:10197106178065 (each) 50197106178063 (case), Lot Number: 6701891 ; 398) SBA95BMHH4, UDI-DI:10197106178065 (each) 50197106178063 (case), Lot Number: 6560936 ; 399) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J3986G ; 400) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J43U62 ; 401) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J30T14 ; 402) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J4679F ; 403) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J30T15 ; 404) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J412H ; 405) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J5678Y ; 406) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J4949D ; 407) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J72P49 ; 408) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J7497Y ; 409) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J8392X ; 410) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: N/A ; 411) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J8123A ; 412) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J6786C ; 413) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J8670R ; 414) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J6910W ; 415) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: J6278C ; 416) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: 5631025 ; 417) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: 5135982 ; 418) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: 5664025 ; 419) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: 5618929 ; 420) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: 6345496 ; 421) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: 6169293 ; 422) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: 6485583 ; 423) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: 6264453 ; 424) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: 6687082 ; 425) SBA95BMHHD, UDI-DI:10888439203721 (each) 50888439203729 (case), Lot Number: 6560934 ; 426) SBA95BMHHE, UDI-DI:10197106164433 (each) 50197106164431 (case), Lot Number: 6907768 ; 427) SBA95BMHHE, UDI-DI:10197106164433 (each) 50197106164431 (case), Lot Number: 6701982 ; 428) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7280045 ; 429) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7332850 ; 430) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7121998 ; 431) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 6701983 ; 432) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7055835 ; 433) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 6987010 ; 434) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7160429 ; 435) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7005451 ; 436) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7260060 ; 437) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7068424 ; 438) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7280044 ; 439) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7280083 ; 440) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7287460 ; 441) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7287492 ; 442) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7287483 ; 443) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7287493 ; 444) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7280050 ; 445) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7331296 ; 446) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7332810 ; 447) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7331297 ; 448) SBA95BMHHF, UDI-DI:10197106333402 (each) 50197106333400 (case), Lot Number: 7332809 …

What the firm is doing

An URGENT: MEDICAL DEVICE CORRECTION OVER LABEL notification letter dated 11/8/24 was sent to customers. If you locate affected product within your facility, please complete the following: 1. QUARANTINE affected kits & ALERT your clinicians of this action 2. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard all CODMAN Patties & Strips included with the Presource product. 3. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648. Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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