McKesson PREVENT HT Blood Collection Needle Safety Mechanism Activation Issue
McKesson PREVENT HT blood collection needles with specific lot numbers may have difficulty activating their safety mechanism. Healthcare facilities should contact the manufacturer for replacement guidance.
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 of a medical device with a potential safety mechanism malfunction. The hazard represents a risk-of-harm to healthcare workers where the safety mechanism may fail to activate. However, no illnesses or injuries are reported in the source material, which limits the classification to 'High' rather than 'Severe.'
Plain-English summary
Zhejiang Kindly Medical Devices Co., Ltd. is recalling the McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder (MFR # 16-NBCH22GS) distributed nationwide. The recall affects devices with specific lot numbers and expiration dates.
The FDA has classified this as a Class II recall due to a potential for difficulty in safety mechanism activation on the affected devices.
The affected lot numbers are: CKDI11-01 (expires 2024-10-01), CKDI12-01 (expires 2024-11-01), CKDJ01-01 (expires 2024-12-01), CKDJ03-01 (expires 2025-02-01), and CKDJ05-01 (expires 2025-04-01). Healthcare facilities with these products should review the FDA recall notice and contact the manufacturer for guidance.
The recalled product
- Product
- McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS
- Manufacturer
- Zhejiang Kindly Medical Devices Co., Ltd.
- Hazard
- safety-mechanism-failure
- needlestick-risk
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 (5)
- Lot Numbers / Expiration Date: CKDI11-01 / Exp. Date 2024-10-01
- CKDI12-01 / Exp. Date 2024-11-01
- CKDJ01-01 / Exp. Date 2024-12-01
- CKDJ03-01 / Exp. Date 2025-02-01
- CKDJ05-01 / Exp. Date 2025-04-01.
Distribution
Distributed nationwide across the United States.
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