| | Class 2 Device Recall Infusomat |  |
| Date Initiated by Firm | October 29, 2025 |
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| Date Posted | November 26, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0640-2026 |
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| Recall Event ID |
97816 |
| 510(K)Number | K142036 |
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| Product Classification |
Set, administration, intravascular - Product Code FPA
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| Product | Infusomat 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 numbers:
1. UNIV.15DROP PUMP SET W/3 SAFELINE LL; 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; Catalog Number: 362032.
2. UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; Catalog Number: 362033.
3. 60DROP METRISET PUMP SET, 3 SAFELINE; Priming volume: 19mL, length: 120in, SafeLine; Catalog Number: 362034.
4. Y TYPE BLOOD PUMP SET, SAFELINE INJ; Priming volume: 39mL, length: 120in, SafeLine; Catalog Number: 362043.
5. UNIV. 15 DROP PUMP SET W/ 0.2 FILTER; 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine; Catalog Number: 362050.
6. SPACE PUMP SET 15 DROP W/2 SAFEDAY; SPACE PUMP SET 15 DROP W/2 SAFEDAY; Catalog Number: 362420.
7. UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL; 15 drops/mL, priming volume: 21mL, length: 120in, ULTRASITE; Catalog Number: 362431.
8. SPACE PUMP IV SET, 120 IN.; 15 drops/mL, priming volume: 21mL, length: 118in, ULTRASITE; Catalog Number: 362432.
9. 60 DROP METRISET PUMP SET,3 SFLINE ASV; Priming volume: 21mL, length: 121in, SafeLine; Catalog Number: 363010.
10. Y-TYPE BLOOD PUMP SET, SAFELINE, ASV; Priming volume: 40mL, length: 123in, SafeLine; Catalog Number: 363019.
11. UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV; 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; Catalog Number: 363030.
12. UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV; 15 drops/mL, priming volume: 22mL, length: 123in, ULTRASITE; Catalog Number: 363230.
13. Y-TYPE BLOOD PUMP SET, CARESITE, ASV; Priming volume: 41mL, length: 120in, CARESITE; Catalog Number: 363419.
14. SPACE PUMP IV SET, 2 CARESITES, ASV; 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; Catalog Number: 363420.
15. UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV; 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; Catalog Number: 363421.
16. 60DROP METRISET PUMP, 3 CARESITES, ASV; Priming volume: 21mL, length: 130in, CARESITE; Catalog Number: 363422.
17. UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV; 60 drops/mL, priming volume: 21mL, length: 118in, CARESITE; Catalog Number: 363423.
18. UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; Catalog Number: 363424.
19. UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; 15 drops/mL, priming volume: 23mL, length: 123in, CARESITE; Catalog Number: 363430.
20. UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; Catalog Number: 363433.
21. SPACE PUMP IV SET 15D, 110 IN.; "SPACE PUMP IV SET 15D, 110 IN.
CLOSE"; Catalog Number: 480254.
22. SPACE PUMP IV SET, 127 IN.; SPACE PUMP IV SET, 127 IN.; Catalog Number: 480255.
23. SPACE PUMP SET 15D, CARESITE LAD 122 IN. ; 15 drops/mL, priming volume: 23mL, length: 122in, CARESITE; Catalog Number: 480256.
24. 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; Catalog Number: 480258.
25. SPACE PUMP IV SET 15D, 90 IN.; SPACE PUMP IV SET 15D, 90 IN.; Catalog Number: 480263.
26. UNIV. 15 DROP PUMP SET W 3 CARESITE L.L.; 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; Catalog Number: 490100.
27. 60 DROP METRISET PUMP SET, 3 CARESITES; Priming volume: 19mL, length: 120in, CARESITE; Catalog Number: 490101. |
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| Code Information |
1. Catalog Number: 362032; Primary UDI-DI: 04046964182556; Unit of Dose UDI-DI: 04046964182549. Shelf Life: Earliest Exp of Comp or 60mths.
2. Catalog Number: 362033; Primary UDI-DI: 04046964837821; Unit of Dose UDI-DI: 04046964837814. Shelf Life: Earliest Exp of Comp or 36mths.
3. Catalog Number: 362034; Primary UDI-DI: 04046964182570; Unit of Dose UDI-DI: 04046964182563. Shelf Life: Earliest Exp of Comp or 48mths.
4. Catalog Number: 362043; Primary UDI-DI: 04046964182631; Unit of Dose UDI-DI: 04046964182624. Shelf Life: Earliest Exp of Comp or 60mths.
5. Catalog Number: 362050; Primary UDI-DI: 04046964182655; Unit of Dose UDI-DI: 04046964182648. Shelf Life: Earliest Exp of Comp or 60mths.
6. Catalog Number: 362420; Primary UDI-DI: 04046955592715; Unit of Dose UDI-DI: 04046955592708. Shelf Life: 36mths from Start Date.
7. Catalog Number: 362431; Primary UDI-DI: 04046964294013; Unit of Dose UDI-DI: 04046964294006. Shelf Life: Earliest Exp of Comp or 60mths.
8. Catalog Number: 362432; Primary UDI-DI: 04046964182679; Unit of Dose UDI-DI: 04046964182662. Shelf Life: Earliest Exp of Comp or 60mths.
9. Catalog Number: 363010; Primary UDI-DI: 04046964294174; Unit of Dose UDI-DI: 04046964294167. Shelf Life: Earliest Exp of Comp or 48mths.
10. Catalog Number: 363019; Primary UDI-DI: 04046964294198; Unit of Dose UDI-DI: 04046964294181. Shelf Life: Earliest Exp of Comp or 60mths.
11. Catalog Number: 363030; Primary UDI-DI: 04046964294259; Unit of Dose UDI-DI: 04046964294242. Shelf Life: Earliest Exp of Comp or 60mths.
12. Catalog Number: 363230; Primary UDI-DI: 04046964294495; Unit of Dose UDI-DI: 04046964294488. Shelf Life: Earliest Exp of Comp or 60mths.
13. Catalog Number: 363419; Primary UDI-DI: 04046964294570; Unit of Dose UDI-DI: 04046964294563. Shelf Life: Earliest Exp of Comp or 36mths.
14. Catalog Number: 363420; Primary UDI-DI: 04046964294594; Unit of Dose UDI-DI: 04046964294587. Shelf Life: Earliest Exp of Comp or 36mths.
15. Catalog Number: 363421; Primary UDI-DI: 04046964294617; Unit of Dose UDI-DI: 04046964294600. Shelf Life: Earliest Exp of Comp or 36mths.
16. Catalog Number: 363422; Primary UDI-DI: 04046964294631; Unit of Dose UDI-DI: 04046964294624. Shelf Life: Earliest Exp of Comp or 36mths.
17. Catalog Number: 363423; Primary UDI-DI: 04046964294655; Unit of Dose UDI-DI: 04046964294648. Shelf Life: Earliest Exp of Comp or 36mths.
18. Catalog Number: 363424; Primary UDI-DI: 04046964837906; Unit of Dose UDI-DI: 04046964837890. Shelf Life: Earliest Exp of Comp or 36mths.
19. Catalog Number: 363430; Primary UDI-DI: 04046964294679; Unit of Dose UDI-DI: 04046964294662. Shelf Life: 36mths from Start Date.
20. Catalog Number: 363433; Primary UDI-DI: 04046964837920; Unit of Dose UDI-DI: 04046964837913. Shelf Life: Earliest Exp of Comp or 36mths.
21. Catalog Number: 480254; Primary UDI-DI: 04046955324798; Unit of Dose UDI-DI: 04046955343904. Shelf Life: Earliest Exp of Comp or 36mths.
22. Catalog Number: 480255; Primary UDI-DI: 04046955324804; Unit of Dose UDI-DI: 04046955585403. Shelf Life: Earliest Exp of Comp or 36mths.
23. Catalog Number: 480256; Primary UDI-DI: 04046955324811; Unit of Dose UDI-DI: 04046955585861. Shelf Life: Earliest Exp of Comp or 36mths.
24. Catalog Number: 480258; Primary UDI-DI: 04046955324835; Unit of Dose UDI-DI: 04046955585885. Shelf Life: Earliest Exp of Comp or 36mths.
25. Catalog Number: 480263; Primary UDI-DI: 04046955693931; Unit of Dose UDI-DI: 04046955693924. Shelf Life: Earliest Exp of Comp or 36mths.
26. Catalog Number: 490100; Primary UDI-DI: 04046964186080; Unit of Dose UDI-DI: 04046964186073. Shelf Life: 36mths from Start Date.
27. Catalog Number: 490101; Primary UDI-DI: 04046964186103; Unit of Dose UDI-DI: 04046964186097. Shelf Life: Earliest Exp of Comp or 36mths.
28. Catalog Number: 490102; Primary UDI-DI: 04046964186127; Unit of Dose UDI-DI: 04046964186110. Shelf Life: Earliest Exp of Comp or 36mths.
29. Catalog Number: 490103; Primary UDI-DI: 04046964302107; Unit of Dose UDI-DI: 04046964302091. Shelf Life: Earliest Exp of Comp or 36mths.
30. Catalog Number: 490104; Primary UDI-DI: 04046964186141; Unit of Dose UDI-DI: 04046964186134. Shelf Life: Earliest Exp of Comp or 36mths.
31. Catalog Number: 490105; Primary UDI-DI: 04046964186165; Unit of Dose UDI-DI: 04046964186158. Shelf Life: Earliest Exp of Comp or 36mths.
32. Catalog Number: 490655; Primary UDI-DI: 04046955836383; Unit of Dose UDI-DI: 04046955836376. Shelf Life: Earliest Exp of Comp or 36mths.
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| FEI Number |
2521402
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Recalling Firm/
Manufacturer |
B Braun Medical Inc
824 12th Ave
Bethlehem PA 18018-3524
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| For Additional Information Contact | Allison Longenhagen
001-484-2408373 |
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Manufacturer Reason
for Recall | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
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FDA Determined
Cause 2 | Process control |
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| Action | 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." |
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| Quantity in Commerce | 49,330,370 |
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| Distribution | Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = FPA
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