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RecallWatchMedical Device Safety
Class IIOngoingZ-0720-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Medline brand

MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesReported Jan 1, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

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.

Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8) ENT HUTCH, SKU DYNJ58856A; 9) PACK NASAL, SKU DYNJ60111A; 10) PACK NASAL, SKU DYNJ60111B; 11) ENT CUSTOM PACK, SKU DYNJ63052C; 12) ENT PACK, SKU DYNJ64256D; 13) FESS/SEPTOPLASTY PACK, SKU DYNJ64509B; 14) SINUS ENDOSCOPY PACK, SKU DYNJ65644; 15) ACOUSTICS SHSC-LF, SKU DYNJ66749; 16) TRANSPHENOIDAL PACK, SKU DYNJ67423A; 17) TRANSPHENOIDAL PACK, SKU DYNJ67423B; 18) ENT PACK, SKU DYNJ68102B; 19) E N T PACK, SKU DYNJ80526B; 20) NASAL PACK, SKU DYNJ81280; 21) ENT FESS PACK, SKU DYNJ81420A; 22) HEAD AND NECK PACK, SKU DYNJ81934; 23) HEAD AND NECK PACK - 51597, SKU DYNJ81934A; 24) HEAD AND NECK ENT PACK, SKU DYNJ83679A; 25) HEAD NECK PACK HC, SKU DYNJ84270; 26) TRANSPHENOIDAL PACK-LF, SKU DYNJ85422; 27) NASAL SEPTAL, SKU DYNJ901299A; 28) NASAL SEPTAL, SKU DYNJ901299B; 29) PACK TRANSPHENOIDAL, SKU DYNJ905685D; 30) SEPTOPLASTY, SKU DYNJ906474C; 31) LEFORTE MANDIBLE, SKU DYNJ906839A; 32) NASAL MHS, SKU DYNJ908545A; 33) NASAL MHS, SKU DYNJ908545B; 34) ENT, SKU DYNJ909128A; 35) ENT, SKU DYNJ909128C; 36) ENT, SKU DYNJ909128D; 37) ENT, SKU DYNJ909128F; 38) SINUS PACK, SKU DYNJ909370

Lot / code information

UDI
CDS982901F, 10889942216970 (each), 40889942216971 (case)
Lot #
23HBQ152
UDI
DYNJ17493G, 10195327224424 (each), 40195327224425 (case)
Lot #
23GBW775
UDI
DYNJ33520A, 10884389851333 (each), 40884389851334 (case)
Lot #
23HDB834
UDI
DYNJ44845G, 10889942712311 (each), 40889942712312 (case)
Lot #
23HBF195
UDI
DYNJ48330B, 10195327113506 (each), 40195327113507 (case)
Lot #
23HBO622
Show 66 more code fields
UDI
DYNJ50572, 10889942008476 (each), 40889942008477 (case)
Lot #
23GBR940
UDI
DYNJ53573A, 10193489201635 (each), 40193489201636 (case)
Lot #
23GBS356
UDI
DYNJ58856A, 10193489750263 (each), 40193489750264 (case)
Lot #
23HBO870
UDI
DYNJ60111A, 10193489246995 (each), 40193489246996 (case)
Lot #
21JMB783 21HMF433 21GMD178 21FMC923 20IMB575
UDI
DYNJ60111B, 10195327527617 (each), 40195327527618 (case)
Lot #
24HMC974 24GMA899 24FMB079 24EMC108 24DMD791 24CMG320
UDI
DYNJ63052C, 10195327101312 (each), 40195327101313 (case)
Lot #
22KME394 22KMA630 22JMD852 22GMG160 22EMG974 22DMF954 22CMC565
UDI
DYNJ64256D, 10195327452773 (each), 40195327452774 (case)
Lot #
23HBA766
UDI
DYNJ64509B, 10195327323745 (each), 40195327323746 (case)
Lot #
23HBC092
UDI
DYNJ65644, 10193489283204 (each), 40193489283205 (case)
Lot #
23HBA753
UDI
DYNJ66749, 10193489375947 (each), 40193489375948 (case)
Lot #
21ABT938 21ABO570 20JBS998 20HBM389
UDI
DYNJ67423A, 10195327163402 (each), 40195327163403 (case)
Lot #
24DLA092 24BLA235 23KLA058 23ILB043 23ILA503 23HLB296 23HLB011 23FLA068 23DLA463 23DLA185 23BLA617 22LLA582 22KLA652 22HLA029 22GLA884
UDI
DYNJ67423B, 10195327686871 (each), 40195327686872 (case)
Lot #
24GLB018 24FLA258 24ELA763 24DLA759
UDI
DYNJ68102B, 10195327699369 (each), 40195327699360 (case)
Lot #
24IBB348 24GBB791 24EBA114
UDI
DYNJ80526B, 10195327211059 (each), 40195327211050 (case)
Lot #
23HBF568
UDI
DYNJ81280, 10195327102968 (each), 40195327102969 (case)
Lot #
22HMF910
UDI
DYNJ81420A, 10195327322601 (each), 40195327322602 (case)
Lot #
24CBL416 23LBK136 23IBR308 23HBD265 23GBJ044 23FBK113 23EBN716 23BBQ143
UDI
DYNJ81934, 10195327156817 (each), 40195327156818 (case)
Lot #
23EBG024 23BBC727 22JBJ632 22HBH399
UDI
DYNJ81934A, 10195327413019 (each), 40195327413010 (case)
Lot #
24DBK564 24DBB486 24CBG998 24BBV700 24ABD320 23HBO084 23GBG012
UDI
DYNJ83679A, 10195327459727 (each), 40195327459728 (case)
Lot #
24HBP441 24GBF665 24BBO428 23LBS373 23JBD663 23IBN314
UDI
DYNJ84270, 10195327349103 (each), 40195327349104 (case)
Lot #
23GBC274
UDI
DYNJ85422, 10195327499716 (each), 40195327499717 (case)
Lot #
24FDA925 24ADB100
UDI
DYNJ901299A, 10889942010349 (each), 40889942010340 (case)
Lot #
21FBC250 20JBO761 20IBH831 20FBM501
UDI
DYNJ901299B, 10193489923384 (each), 40193489923385 (case)
Lot #
22FBU440 22OBC118 22OBC120 22ABA377 21JBJ197 21IBM868 21GBO441
UDI
DYNJ905685D, 10198459024139 (each), 40198459024130 (case)
Lot #
24IDB382
UDI
DYNJ906474C, 10195327221355 (each), 40195327221356 (case)
Lot #
24HDA228 24EDA811 24DDB542 23LDB493 23GDA771 23DDA732 22IDB976
UDI
DYNJ906839A, 10195327092528 (each), 40195327092529 (case)
Lot #
22JMB394
UDI
DYNJ908545A, 10195327384166 (each), 40195327384167 (case)
Lot #
23JBV681
UDI
DYNJ908545B, 10195327593124 (each), 40195327593125 (case)
Lot #
24HBI988 24FBS776 24FBA297 24ABT058
UDI
DYNJ909128A, 10195327326739 (each), 40195327326730 (case)
Lot #
23EBD903 23DBD851
UDI
DYNJ909128C, 10195327458416 (each), 40195327458417 (case)
Lot #
23JBO251 23HBI313
UDI
DYNJ909128D, 10195327516321 (each), 40195327516322 (case)
Lot #
24EBC023 24CBK211 24BBM816 24ABR742 23LBQ695 23LBM416
UDI
DYNJ909128F, 10198459055256 (each), 40198459055257 (case)
Lot #
24HBV054 24GBN495
UDI
DYNJ909370, 10195327319038 (each), 40195327319039 (case)
Lot #
24BMA818 24AMG256 23LMF420 23LMB722 23LMA458 23CME287

What the firm is doing

An IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification letter dated 11/7/24 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-209-FGX1 Recall Code: Recall Code 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

DistributionShow details

US Nationwide. Canada.

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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