Z-1273-2022 Class II Ongoing
FDA device recall Z-1273-2022 was initiated by Bard Peripheral Vascular Inc on April 22, 2022 and is designated Class II. Reason for recall: There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set… The recall status is ongoing. Affected quantity: 1460 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 29, 2022
- Initiation Date
- April 22, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1460 units
Product Description
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Reason for Recall
There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of MS, NC, FL, KS, GA, OH, AZ, NV, OH, IL, MI, MO,IA, CA, PA, AL,WA, TN, IN, NY and the countries of AU, BE, NZ.
Code Information
Lot # 0001405396; UDI/DI: (01)10885403076114