B Braun Medical Inc recalls IV Administration Set utilized in gravity IV administration sets and pump administratio…
Reason for recall
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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.
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DR W/2 SAFEDAY; Catalog Number: 352636. 2. IV ADMIN SET 15 DR W/2 SAFEDAY 84 IN.; Catalog Number: 352639. 3. IV ADMIN SET 15 DROP W/3 SAFEDAY; Catalog Number: 352640. 4. IV ADMIN 15D W/2 SAFEDAY & 0.2 FILTER; Catalog Number: 352643. 5. IV ADMIN SET, 105 IN.; Catalog Number: 477003. 6. IV ADMIN SET 15D, 4 CARESTIE LAD, 145 IN; Catalog Number: 477006. 7. IV ADMIN SET, 121 IN.; Catalog Number: 477008. 8. IV ADMIN SET 15D, CARESTIE LAD, 90 IN; Catalog Number: 477012. 9. IV ADMIN SET, 2 CARESTIE LAD, 15D, 117IN; Catalog Number: 477019. 10. IV ADMIN SET, 15D, 5CARESITE LAD, 136 IN; Catalog Number: 477021. 11. IV ADMIN SET 114 IN.; Catalog Number: 477022. 12. IV ADMIN SET 5 CARESITE LADS, 126 IN.; Catalog Number: 477023. 13. IV SET 15DR 3 SAFEDAY, 106 IN.; Catalog Number: 477053. 14. IV ADMIN SET, 15DR, CARESITE LAD, 121 IN; Catalog Number: 490513. 15. IV ADMIN SET, 15D, 120 IN.; Catalog Number: 490521. 16. IV ADMIN SET 15D 2 CARESITE LADS, 112IN.; Catalog Number: 490527. 17. IV ADMIN SET 15 DRP CARESITE SAFEPORT; Catalog Number: 490529. 18. IV ADMIN SET, 15D, 139 IN.; Catalog Number: 490535. 19. IV ADMIN SET 15D, CARESITE LAD, 122IN.; Catalog Number: 490543. 20. IV ADMIN SET 15D 3 CARESITE LADS, 150IN.; Catalog Number: 490546. 21. IV ADMIN SET, 125 IN.; Catalog Number: 490547. 22. IV ADMIN SET 15D, 5 CARESITE INJ, 150in.; Catalog Number: 490552. 23. IV ADMIN SET, 120IN.; Catalog Number: 490553. 24. IV ADMIN SETW/ B/C VLV 3 CARESITE 134IN.; Catalog Number: 490554. 25. IV ADMIN SET 15DR w/3 B/C VLV, 124 IN.; Catalog Number: 490555. 26. IV ADMIN SET 15D w/B/C VLV, 139 IN.; Catalog Number: 490558. 27. IV ADMINISTRATION SET, 117 IN.; Catalog Number: 490559. 28. IV ADMINISTRATION SET, 108 IN.; Catalog Number: 490560. 29. IV ADMINISTRATION SET, 134 IN.; Catalog Number: 490561. 30. IV ADMIN SET 15D w/B/C VLV, 140 IN.; Catalog Number: 490562. 31. IV ADMIN SET, 111 IN.; Catalog Number: 490563. 32. IV ADMIN SET 15D 2 CARESITE LADS, 122 IN; Catalog Number: 490569. 33. IV ADMIN SET 15D STOPCOCK, DUAL MANIFOLD; Catalog Number: 490573. 34. IV ADMIN SET 15D w/B/C VLV, 110 IN.; Catalog Number: 490574. 35. IV ADMIN 15D 5 CARESITE LADS STPCK 120in; Catalog Number: 490575. 36. IV ADMIN SET 15D 5 CARESITE LADS, 140 IN; Catalog Number: 490578. 37. IV ADMIN SET W/15D, 4 CARESITE LADS; Catalog Number: 490581. 38. IV ADMIN 15D CARESITE LADS, STPCK 134 IN; Catalog Number: 490582. 39. IV ADMIN SET, 15D, 108 IN.; Catalog Number: 490583. 40. IV ADMIN SET, 10 DROP, 130 IN.; Catalog Number: 490588. 41. IV ADMIN SET, 132 IN.; Catalog Number: 490589. 42. IV ADMIN SET, 15DR, 105 IN.; Catalog Number: 490600. 43. IV ADMIN SET,3 CARESITE,3 HF SPCK, 129IN; Catalog Number: 490607. 44. IV SET 15DR 3CARESITE 2STOPCOCK, 126IN; Catalog Number: 490608. 45. IV ADMIN SET 15D 2 CARESITE LADS, 138 IN; Catalog Number: 490615. 46. IV SET 15DR 2SAFEDAY 2SAFEPORT, 99 IN.; Catalog Number: 490618. 47. IV SET 60DR 2SAFEDAY 2SAFEPORT, 99 IN.; Catalog Number: 490619. 48. IV ADMIN SET 15 DRPS 4W STOPCOCK W/ C&S; Catalog Number: 490644. 49. IV ADMIN SET 15 DRPS ULTRAP. ZERO 90.6IN; Catalog Number: 490657. 50. IV ADMIN SET 15 DRPS STOPCOCK MALE 117IN; Catalog Number: 490658.
Lot / code information
- Catalog #
- 352636; Primary
- UDI
- 04046955594597; Unit of Dose
- UDI
- 04046955594580; Expiration Date: 36mths from Start Date. 2
- Catalog #
- 352639; Primary
- UDI
- 04046955594672; Unit of Dose
- UDI
- 04046955594665; Expiration Date: 36mths from Start Date. 3
- Catalog #
- 352640; Primary
- UDI
- 04046955594696; Unit of Dose
- UDI
- 04046955594689; Expiration Date: 36mths from Start Date. 4
- Catalog #
- 352643; Primary
- UDI
- 04046955594757; Unit of Dose
- UDI
- 04046955594740; Expiration Date: 36mths from Start Date. 5
- Catalog #
- 477003; Primary
- UDI
- 04046955202836; Unit of Dose
- UDI
- 04046955202829; Expiration Date: Earliest Exp of Comp or 36mths. 6
- Catalog #
- 477006; Primary
- UDI
- 04046955202751; Unit of Dose
- UDI
- 04046955202744; Expiration Date: Earliest Exp of Comp or 36mths. 7
- Catalog #
- 477008; Primary
- UDI
- 04046955202850; Unit of Dose
- UDI
- 04046955202843; Expiration Date: Earliest Exp of Comp or 36mths. 8
- Catalog #
- 477012; Primary
- UDI
- 04046955202874; Unit of Dose
- UDI
- 04046955202867; Expiration Date: Earliest Exp of Comp or 36mths. 9
- Catalog #
- 477019; Primary
- UDI
- 04046955203147; Unit of Dose
- UDI
- 04046955203130; Expiration Date: Earliest Exp of Comp or 36mths. 10
- Catalog #
- 477021; Primary
- UDI
- 04046955269983; Unit of Dose
- UDI
- 04046955269976; Expiration Date: Earliest Exp of Comp or 36mths. 11
- Catalog #
- 477022; Primary
- UDI
- 04046955270002; Unit of Dose
- UDI
- 04046955269990; Expiration Date: Earliest Exp of Comp or 36mths. 12
- Catalog #
- 477023; Primary
- UDI
- 04046955270026; Unit of Dose
- UDI
- 04046955270019; Expiration Date: Earliest Exp of Comp or 36mths. 13
- Catalog #
- 477053; Primary
- UDI
- 04046955672431; Unit of Dose
- UDI
- 04046955672424; Expiration Date: Earliest Exp of Comp or 36mths. 14
- Catalog #
- 490513; Primary
- UDI
- 04046955137237; Unit of Dose
- UDI
- 04046955137220; Expiration Date: Earliest Exp of Comp or 36mths. 15
- Catalog #
- 490521; Primary
- UDI
- 04046955185252; Unit of Dose
- UDI
- 04046955186563; Expiration Date: Earliest Exp of Comp or 24mths. 16
- Catalog #
- 490527; Primary
- UDI
- 04046955203222; Unit of Dose
- UDI
- 04046955203215; Expiration Date: Earliest Exp of Comp or 36mths. 17
- Catalog #
- 490529; Primary
- UDI
- 04046955203307; Unit of Dose
- UDI
- 04046955203291; Expiration Date: Earliest Exp of Comp or 24mths. 18
- Catalog #
- 490535; Primary
- UDI
- 04046955203406; Unit of Dose
- UDI
- 04046955203390; Expiration Date: Earliest Exp of Comp or 36mths. 19
- Catalog #
- 490543; Primary
- UDI
- 04046955270200; Unit of Dose
- UDI
- 04046955270194; Expiration Date: Earliest Exp of Comp or 36mths. 20
- Catalog #
- 490546; Primary
- UDI
- 04046955270262; Unit of Dose
- UDI
- 04046955270255; Expiration Date: Earliest Exp of Comp or 36mths. 21
- Catalog #
- 490547; Primary
- UDI
- 04046955270286; Unit of Dose
- UDI
- 04046955270279; Expiration Date: Earliest Exp of Comp or 36mths. 22
- Catalog #
- 490552; Primary
- UDI
- 04046955275342; Unit of Dose
- UDI
- 04046955275335; Expiration Date: Earliest Exp of Comp or 36mths. 23
- Catalog #
- 490553; Primary
- UDI
- 04046955275366; Unit of Dose
- UDI
- 04046955275359; Expiration Date: Earliest Exp of Comp or 36mths. 24
- Catalog #
- 490554; Primary
- UDI
- 04046955275380; Unit of Dose
- UDI
- 04046955275373; Expiration Date: Earliest Exp of Comp or 36mths. 25
- Catalog #
- 490555; Primary
- UDI
- 04046955275403; Unit of Dose
- UDI
- 04046955275397; Expiration Date: Earliest Exp of Comp or 36mths. 26
- Catalog #
- 490558; Primary
- UDI
- 04046955275465; Unit of Dose
- UDI
- 04046955275458; Expiration Date: Earliest Exp of Comp or 36mths. 27
- Catalog #
- 490559; Primary
- UDI
- 04046955275489; Unit of Dose
- UDI
- 04046955275472; Expiration Date: Earliest Exp of Comp or 36mths. 28
- Catalog #
- 490560; Primary
- UDI
- 04046955275502; Unit of Dose
- UDI
- 04046955275496; Expiration Date: Earliest Exp of Comp or 36mths. 29
- Catalog #
- 490561; Primary
- UDI
- 04046955275526; Unit of Dose
- UDI
- 04046955275519; Expiration Date: Earliest Exp of Comp or 36mths. 30
- Catalog #
- 490562; Primary
- UDI
- 04046955275540; Unit of Dose
- UDI
- 04046955275533; Expiration Date: Earliest Exp of Comp or 36mths. 31
- Catalog #
- 490563; Primary
- UDI
- 04046955275564; Unit of Dose
- UDI
- 04046955275557; Expiration Date: Earliest Exp of Comp or 36mths. 32
- Catalog #
- 490569; Primary
- UDI
- 04046955275687; Unit of Dose
- UDI
- 04046955275670; Expiration Date: Earliest Exp of Comp or 36mths. 33
- Catalog #
- 490573; Primary
- UDI
- 04046955287451; Unit of Dose
- UDI
- 04046955287444; Expiration Date: Earliest Exp of Comp or 24mths. 34
- Catalog #
- 490574; Primary
- UDI
- 04046955287475; Unit of Dose
- UDI
- 04046955287468; Expiration Date: Earliest Exp of Comp or 24mths. 35
- Catalog #
- 490575; Primary
- UDI
- 04046955287499; Unit of Dose
- UDI
- 04046955287482; Expiration Date: Earliest Exp of Comp or 36mths. 36
- Catalog #
- 490578; Primary
- UDI
- 04046955287550; Unit of Dose
- UDI
- 04046955287543; Expiration Date: Earliest Exp of Comp or 36mths. 37
- Catalog #
- 490581; Primary
- UDI
- 04046955287611; Unit of Dose
- UDI
- 04046955287604; Expiration Date: Earliest Exp of Comp or 24mths. 38
- Catalog #
- 490582; Primary
- UDI
- 04046955287635; Unit of Dose
- UDI
- 04046955287628; Expiration Date: Earliest Exp of Comp or 36mths. 39
- Catalog #
- 490583; Primary
- UDI
- 04046955287659; Unit of Dose
- UDI
- 04046955287642; Expiration Date: Earliest Exp of Comp or 60mths. 40
- Catalog #
- 490588; Primary
- UDI
- 04046955287758; Unit of Dose
- UDI
- 04046955287741; Expiration Date: Earliest Exp of Comp or 36mths. 41
- Catalog #
- 490589; Primary
- UDI
- 04046955287772; Unit of Dose
- UDI
- 04046955287765; Expiration Date: Earliest Exp of Comp or 36mths. 42
- Catalog #
- 490600; Primary
- UDI
- 04046955352777; Unit of Dose
- UDI
- 04046955352760; Expiration Date: Earliest Exp of Comp or 24mths. 43
- Catalog #
- 490607; Primary
- UDI
- 04046955352913; Unit of Dose
- UDI
- 04046955352906; Expiration Date: Earliest Exp of Comp or 36mths. 44
- Catalog #
- 490608; Primary
- UDI
- 04046955352937; Unit of Dose
- UDI
- 04046955352920; Expiration Date: Earliest Exp of Comp or 36mths. 45
- Catalog #
- 490615; Primary
- UDI
- 04046955664672; Unit of Dose
- UDI
- 04046955664665; Expiration Date: Earliest Exp of Comp or 36mths. 46
- Catalog #
- 490618; Primary
- UDI
- 04046955664733; Unit of Dose
- UDI
- 04046955664726; Expiration Date: Earliest Exp of Comp or 24mths. 47
- Catalog #
- 490619; Primary
- UDI
- 04046955664757; Unit of Dose
- UDI
- 04046955664740; Expiration Date: Earliest Exp of Comp or 24mths. 48
- Catalog #
- 490644; Primary
- UDI
- 04046955765003; Unit of Dose
- UDI
- 04046955764990; Expiration Date: Earliest Exp of Comp or 36mths. 49
- Catalog #
- 490657; Primary
- UDI
- 04046955836420; Unit of Dose
- UDI
- 04046955836413; Expiration Date: Earliest Exp of Comp or 36mths. 50
- Catalog #
- 490658; Primary
- UDI
- 04046955836697; Unit of Dose
- UDI
- 04046955836680; Expiration Date: Earliest Exp of Comp or 36mths
Show 140 more code fieldsShow fewer
What the firm is doing
B Braun notified consignees on about 10/29/2025 via letter. Consignees were instructed to follow "Interim Measures for Users" as outlined in the letter for secondary infusions via gravity sets and if using secondary infusions with infusion pumps. Consignees were also instructed to inform all users and post the applicable attachment(s) in care areas where secondary infusions may be administered and where IV administration sets and pump administration sets may be stored until further notice. B. Braun will provide additional notification when users may resume their normal secondary administration process without the need for the modified workflow. Consider priming all IV administration sets and pump administration sets with normal saline or other standard solutions prior to priming with expensive medications to avoid loss of expensive medications or occupational exposure to hazardous medications in the event the set is unable to be primed. If difficulty priming is encountered, obtain a replacement device and file a customer complaint with B. Braun. Additionally, consignees were requested to ensure all pertinent employees and customers are informed, post the notification where affected products are stored, and complete and return the "Urgent Medical Device Correction Acknowledgement Form."
DistributionShow detailsHide
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0670-2026
- FDA 510(k) clearance · K170595The device's official FDA premarket clearance record
- FDA device classification · FPAOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5440The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find B Braun Medical IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
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 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.
More Class II recalls
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…
Due to catheter separation
- Aortic Aneurysm Treatment Endovascular Graft System
- Under Investigation by firm