Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported December 13, 2023
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL, length: 120in, SafeLine; 362035 INFUSOMAT SPACE PUMP IV SET; 362043 Priming volume: 39mL, length: 120in, SafeLine; 362050 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine; 362420 SPACE
In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the in…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
B. Braun Medical, Inc. recalled Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with … - a critical-severity action.
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with … was recalled by B. Braun Medical, Inc. in December 13, 2023. Reason: In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Bo…. Check the official notice for the remedy. Verify recall #Z-0355-2024 with the FDA Devices before acting.
The recall
B. Braun Medical, Inc. issued this critical-severity FDA Devices recall-In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Bo….
- Critical
- severity level
- 33.8M units
- affected scope
- Class I
- classification
- December 13, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0355-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0355-2024) was formally reported on December 13, 2023, with the manufacturer initiating the action on November 1, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. B. Braun Medical, Inc. is listed as the recalling firm, operating out of Allentown, PA. Federal records list the affected scope as 33,820,976 units, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interrupti… Distribution data in the federal record shows the product reached: Distribution US nationwide, Canada and Germany.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
33,820,976 units
Related Recalls
6
3 from same agency
Product description
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL, length: 120in, SafeLine; 362035 INFUSOMAT SPACE PUMP IV SET; 362043 Priming volume: 39mL, length: 120in, SafeLine; 362050 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine; 362420 SPACE PUMP SET 15 DROP W/2 SAFEDAY; 362432 15 drops/mL, priming volume: 21mL, length: 118in, ULTRASITE; 362911 Priming volume: 14mL, length: 84in, CARESITE, Spin-Lock; 363010 Priming volume: 21mL, length: 121in, SafeLine; 363019 Priming volume: 40mL, length: 123in, SafeLine; 363030 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 363032 20 drops/mL, priming volume: 20mL, length: 119in, SafeLine; 363230 15 drops/mL, priming volume: 22mL, length: 123in, ULTRASITE; 363410 15 drops/mL, priming volume: 23mL, length: 119in, CARESITE; 363419 Priming volume: 41mL, length: 120in, CARESITE; 363420 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; 363421 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 363422 Priming volume: 21mL, length: 130in, CARESITE; 363423 60 drops/mL, priming volume: 21mL, length: 118in, CARESITE; 363424 UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; 363430 15 drops/mL, priming volume: 23mL, length: 123in, CARESITE; 363433 UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; 363901 60 drops/mL, priming volume: 11mL, length: 129in; 363902 Priming volume: 25mL, length: 130in; 363904 UNIV. 15 DROP PUMP SET, ASV; 470119 15 drops/mL, priming volume: 23mL, length: 119in, CARESITE; 480254 SPACE PUMP IV SET 15D, 110 IN.; 480255 SPACE PUMP IV SET, 127 IN; 480257 60 DROP NITRO SPACE SET, 88 IN.; 480258 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; 480263 SPACE PUMP IV SET 15D, 90 IN.; 480264 SPACE PUMP IV SET, 15 DRPS/ML, 95 IN.; 490037 Priming volume: 25mL, length: 136in; 490038 60 drops/mL, priming volume: 11mL, length: 129in; 490100 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 490101 Priming volume: 19mL, length: 120in, CARESITE; 490102 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 490103 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; 490104 60 drops/mL, priming volume: 21mL, length: 115in, CARESITE; 490105 Priming volume: 39mL, length: 120in, CARESITE
Reason for recall
In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0355-2024 |
| Date reported | December 13, 2023 |
| Date initiated | November 1, 2023 |
| Recalling firm | B. Braun Medical, Inc. |
| Firm location | Allentown, PA |
| Affected scope | 33,820,976 units |
| Distribution | Distribution US nationwide, Canada and Germany. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0355-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL, length: 120in, SafeLine; 362035 INFUSOMAT SPACE PUMP IV SET; 362043 Priming volume: 39mL, length: 120in, SafeLine; 362050 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine; 362420 SPACE PUMP SET 15 DROP W/2 SAFEDAY; 362432 15 drops/mL, priming volume: 21mL, length: 118in, ULTRASITE; 362911 Priming volume: 14mL, length: 84in, CARESITE, Spin-Lock; 363010 Priming volume: 21mL, length: 121in, SafeLine; 363019 Priming volume: 40mL, length: 123in, SafeLine; 363030 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 363032 20 drops/mL, priming volume: 20mL, length: 119in, SafeLine; 363230 15 drops/mL, priming volume: 22mL, length: 123in, ULTRASITE; 363410 15 drops/mL, priming volume: 23mL, length: 119in, CARESITE; 363419 Priming volume: 41mL, length: 120in, CARESITE; 363420 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; 363421 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 363422 Priming volume: 21mL, length: 130in, CARESITE; 363423 60 drops/mL, priming volume: 21mL, length: 118in, CARESITE; 363424 UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; 363430 15 drops/mL, priming volume: 23mL, length: 123in, CARESITE; 363433 UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; 363901 60 drops/mL, priming volume: 11mL, length: 129in; 363902 Priming volume: 25mL, length: 130in; 363904 UNIV. 15 DROP PUMP SET, ASV; 470119 15 drops/mL, priming volume: 23mL, length: 119in, CARESITE; 480254 SPACE PUMP IV SET 15D, 110 IN.; 480255 SPACE PUMP IV SET, 127 IN; 480257 60 DROP NITRO SPACE SET, 88 IN.; 480258 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; 480263 SPACE PUMP IV SET 15D, 90 IN.; 480264 SPACE PUMP IV SET, 15 DRPS/ML, 95 IN.; 490037 Priming volume: 25mL, length: 136in; 490038 60 drops/mL, priming volume: 11mL, length: 129in; 490100 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 490101 Priming volume: 19mL, length: 120in, CARESITE; 490102 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 490103 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; 490104 60 drops/mL, priming volume: 21mL, length: 115in, CARESITE; 490105 Priming volume: 39mL, length: 120in, CARESITE. Recalled by B. Braun Medical, Inc.. Units affected: 33,820,976 units.
Why was this product recalled? ▼
In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2023. Severity: Critical. Recall number: Z-0355-2024.
Where was the recalled product distributed? ▼
Distribution: Distribution US nationwide, Canada and Germany..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0355-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 13, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.