Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0179-2022 · Posted 2021-10-27

Recall StatusTerminated
Date Initiated2021-09-27
Date Terminated2023-05-04
Product Quantity8,000 units

Reason for Recall

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

Firm Action

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

Root Cause

Equipment maintenance

Distribution Pattern

TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑