Z-0179-2022Class II

BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain...

Name: Z-0179-2022 BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain...
Creator: Becton Dickinson & Company
Published: 2021-09-27
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2021-09-27 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf... on 2021-09-27. FDA classified it as Class II and gives the reason as "Holes in product packaging impacts package integrity and may compromise sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0179-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-27
Posted: 2021-10-27
Terminated: 2023-05-04
Recalling firm: Becton Dickinson & Co
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
Reason for recall: Holes in product packaging impacts package integrity and may compromise sterility.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
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
Quantity in commerce: 8,000 units
Distribution: TX
Product codes and lots: Lot Number: 1111347 Exp. Date: 4/30/2026 UDI: 10382903058225

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0179-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0179-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-03	2021-10-27

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)