B. Braun Central Venous Catheter Tray Recalled for Incorrect Expiration Date Label
Medical Action Industries is recalling 240 cases of B. Braun CARESITE Port Access Kits (REF 375214) due to incorrect expiration date labeling. The kits show an expiration date of 02/21/2024 when the actual expiration is 02/10/2024.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall concerning a critical cardiac product with an expiration date labeling error. The hazard—use of expired sterile medical devices in cardiac procedures—poses risk of harm, though no illnesses or injuries are currently reported.
Plain-English summary
B. Braun CARESITE Port Access Kit with Tegaderm (REF 375214), a central venous catheter tray for cardiac procedures, is being recalled. The product was distributed nationwide, with notable distribution in Pennsylvania. The recall affects 240 cases, each containing 20 units (batch/lot 298442, UDI/DI 10809160283875).
The recall was initiated due to incorrect labeling of the expiration date. The kits were labeled with an expiration date of 02/21/2024 instead of the correct expiration date of 02/10/2024. This discrepancy could result in the use of expired medical devices in cardiac procedures without proper awareness.
The recalled product
- Product
- B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
- Manufacturer
- Medical Action Industries, Inc. 306
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 10809160283875
- Batch/Lot number 298442
Distribution
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