Z-1109-2021 Class II Terminated
FDA device recall Z-1109-2021 was initiated by Becton Dickinson & Company on December 23, 2020 and is designated Class II. Reason for recall: The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe. The recall status is terminated (terminated November 21, 2022). Affected quantity: 155,200 needles.
Recall Details
- Product Type
- Devices
- Report Date
- February 24, 2021
- Initiation Date
- December 23, 2020
- Termination Date
- November 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 155,200 needles
Product Description
BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
Reason for Recall
The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.
Distribution Pattern
Distribution US nationwide and Canada
Code Information
Catalog (Ref No.) 305482 100/package UDI 00382903054824 Lot # 8142303 exp date 31-May-2023