Z-1784-2021 Class I Terminated
FDA device recall Z-1784-2021 was initiated by Avid Medical, Inc. on April 9, 2021 and is designated Class I. Reason for recall: Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow As… The recall status is terminated (terminated July 18, 2022). Affected quantity: 130 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 16, 2021
- Initiation Date
- April 9, 2021
- Termination Date
- July 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130 kits
Product Description
ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
Reason for Recall
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
Distribution Pattern
Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN
Code Information
Part Number: LAKC001-04; Package GTIN: 20809160261016; Lot Number: 1404809 (Expiration Date: 08/01/2021) and 1408337 (Expiration Date: 09/01/2021) Part Number: LAKC001-04; Package GTIN: 20809160293130; Lot Number: 1427628 (Expiration Date: 09/01/2021) Part Number: LAKC001-04; Package GTIN: 20809160313005; Lot number: 1427629 (Expiration Date: 09/01/2021), 1432814 (Expiration Date: 11/30/2021), and 1436046 (Expiration Date: 11/30/2021)