Class II Recall

Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space L

Summary

The FDA issued a Class II for Infusomat utilized in gravity IV administration sets and pump administration set by B Braun Medical Inc. Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion)..

Details

Source

Device Recall

External ID

Z-0640-2026

Action Date

2025-12-03

Status

Ongoing

Product Description

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.

Lot/Code Info: 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.

Quantity Affected: 49,330,370

Reason for Recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Distribution

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-10-29

Company

B Braun Medical Inc

Bethlehem, PA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 254 device recalls issued in the same week, part of 403 device-related FDA actions this month.

B Braun Medical Inc has 282 FDA actions in our database, including 269 recalls and 13 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B Braun Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does B Braun Medical Inc have FDA actions?

B Braun Medical Inc has 282 FDA actions in our database, including 269 recalls and 13 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0640-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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