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U.S. Department of Health and Human Services

Class 2 Device Recall BD Syringe Tip Cap Bulk Sterile Convenience Pak

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 Class 2 Device Recall BD Syringe Tip Cap Bulk Sterile Convenience Paksee related information
Date Initiated by FirmSeptember 27, 2021
Date PostedOctober 27, 2021
Recall Status1 Terminated 3 on May 04, 2023
Recall NumberZ-0179-2022
Recall Event ID 88805
ProductBD 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
Code Information Lot Number: 1111347 Exp. Date: 4/30/2026 UDI: 10382903058225
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactSAME
201-847-6800
Manufacturer Reason
for Recall		Holes in product packaging impacts package integrity and may compromise sterility.
FDA Determined
Cause 2		Equipment maintenance
ActionBD 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
Quantity in Commerce8,000 units
DistributionTX
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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