FDA Device Recalls

Recalls /

#189595

Product

BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822

Affected lot / code info
Lot Number: 1111347 Exp. Date: 4/30/2026 UDI: 10382903058225

Why it was recalled

Holes in product packaging impacts package integrity and may compromise sterility.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

BD notified consignees Urgent Medical DevIce Recall Letter dated 9/7/21 via FedEx and may also be contacted via e-mail (when available). Letter states reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog (Ref) and Lot number listed above. Destroy all product subject to the recall following your institution s process for destruction. 2. Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process any applicable product replacement. 4. Report any adverse health consequences experienced with the use of this product to BD. BD will provide replacement product for all discarded inventory. Contact Information: If you require further assistance, please contact: BD Contact Contact Information North American Regional Complaint Center 1-84BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT

Recalling firm

Firm
Becton Dickinson & Company
Address
1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern
TX

Timeline

Recall initiated
2021-09-27
Posted by FDA
2021-10-27
Terminated
2023-05-04
Status

Source: openFDA Device Recall endpoint. Recall record ID #189595. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.