FDA Recalls Catheter Drainage Kits With Wrong Needle Size
Bard Peripheral Vascular Inc is recalling certain catheter drainage kits that may contain an 8 Fr needle instead of the correct 6 Fr needle. The incorrect needle size could cause tissue injury during patient care.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with potential for patient harm due to mechanical defect, but no reported injuries or illnesses. Per the rubric, a risk-of-harm product where injury has not yet been reported scores 3 (High).
Plain-English summary
Bard Peripheral Vascular Inc is recalling approximately 1460 units of its Safe-t-Centesis Catheter Drainage Kit (REF: PIG1260K, 6Fr, X10, Sterile EO) due to a manufacturing defect.
The recalled kits may contain an 8 Fr needle instead of the specified 6 Fr needle. This size mismatch could complicate proper insertion and use with standard drainage procedures, including universal extension sets, drainage bags, vacuum bottles, and wall suction systems.
The affected products were distributed worldwide, including to health care facilities in 19 US states (MS, NC, FL, KS, GA, OH, AZ, NV, IL, MI, MO, IA, CA, PA, AL, WA, TN, IN, NY) and internationally to Australia, Belgium, and New Zealand. The lot number affected is 0001405396 (UDI/DI: (01)10885403076114).
If you have received this product, contact Bard Peripheral Vascular Inc immediately. Do not use the affected kits. Work with your facility's clinical leadership on replacement options and proper disposal.
The recalled product
- Product
- REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- needle-size-mismatch
- device-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 0001405396
- UDI/DI: (01)10885403076114
Distribution
Distributed nationwide across the United States.
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