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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun CARESITE

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 Class 2 Device Recall B. Braun CARESITEsee related information
Date Initiated by FirmSeptember 15, 2022
Date PostedNovember 18, 2022
Recall Status1 Terminated 3 on February 19, 2025
Recall NumberZ-0265-2023
Recall Event ID 91017
Product Classification Central venous catheter tray - Product Code OFF
ProductB. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
Code Information UDI/DI 10809160283875, Batch/Lot number 298442
FEI Number 1030451
Recalling Firm/
Manufacturer		 Medical Action Industries, Inc. 306
25 Heywood Rd
Arden NC 28704-9302
Manufacturer Reason
for Recall		The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.
FDA Determined
Cause 2		Under Investigation by firm
ActionOwens & Minor/Medical Action INDUSTRIES, INC. issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its sole consignee on 09/23/2022 by email. The notices explained the issue and requested they take the following actions: "Please review your inventory, and segregate and quarantine all affected Kits. If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. A labeling template is enclosed for printing labels which can be affixed on all affected kits in inventory. This label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If you prefer to have labels printed for your facility, please send quantity and end-user information to quality@owens-minor.com. Any adverse events associated with the use of the affected products should be reported to Quality@owens-minor.com. The FDA requires that we account for all affected products. Therefore, please complete the attached Response Form and return to Quality@owens-minor.com as soon as possible even if you have no current product inventory. If you have any questions, please send an email to marlene.jones@owens-minor.com."
Quantity in Commerce240 cases of 20 units
DistributionUS Nationwide distribution in the state of Pennsylvania.
Total Product Life CycleTPLC Device Report
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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