REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Check against the official notice below — it lists the full affected range.
Bard Peripheral Vascular Inc. is recalling approximately 1,460 units of the 6Fr, X10, Safe-t-Centesis Catheter Drainage Kit (Lot #0001405396) because some kits may contain an 8 Fr needle instead of the correct 6 Fr needle. The affected kits are used for drainage procedures in conjunction with universal extension sets, drainage bags, vacuum bottles, or wall suction. The product was distributed worldwide, including in the United States across multiple states (MS, NC, FL, KS, GA, OH, AZ, NV, IL, MI, MO, IA, CA, PA, AL, WA, TN, IN, NY) and in Australia, Belgium, and New Zealand.
The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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. Quantity: 1460 units Lot/code info: Lot # 0001405396; UDI/DI: (01)10885403076114
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.