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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1,460
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
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