CLASS II Device recall · Reported 30 Nov 2022 · FDA Enforcement Report
B. Braun Caresite Port Access Kit w/Tegaderm recalled
Medical Action Industries Inc. 306 is recalling B. Braun Caresite Port Access Kit w/Tegaderm, distributed nationwide in the US. The recall was initiated on 15 Sep 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0265-2023
- FDA event ID
- 91017
- Recalling firm
- Medical Action Industries Inc. 306, Arden, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Sep 2022
- FDA classified
- 18 Nov 2022
- Reported
- 30 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 15 Sep 2022 | Recall initiated by company | |
| 18 Nov 2022 | Classified by FDA | +64 days |
| 30 Nov 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.
Product as listed by the FDA
B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
Where it was distributed
US Nationwide distribution in the state of Pennsylvania.
Questions about this recall
Why was it recalled?
The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.
Which lots are affected?
UDI/DI 10809160283875, Batch/Lot number 298442
Where was it sold?
US Nationwide distribution in the state of Pennsylvania.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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