Arrow Percutaneous Sheath Introducer Kit Recalled for Needlestick Injury Risk
Arrow International is recalling Percutaneous Sheath Introducer Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reports of needlestick injuries, which aligns with the rubric criteria for Severe severity involving significant injury reports.
Plain-English summary
Arrow International Inc. has initiated a Class II recall of the Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath. The recall is driven by reports of safety cover disengagement and needlestick injuries involving the BD Eclipse Needle, which is packaged with certain Arrow products.
The affected product is identified by material number ASK-29803-MM. The company reports that a total of 43,394 devices were distributed nationwide. The sheath is intended for venous access and catheter introduction to the central circulation and features an antimicrobial surface to help protect against sheath-related infections.
Healthcare providers and facilities should stop using the affected kits and contact Arrow International for further instructions on handling the recalled devices.
The recalled product
- Product
- Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters The Arrow¿ Percutaneous Sheath Introducer permits venous access and catheter…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Vascular Access
- Affected units
- 43,394
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 (1)
- Material number ASK-29803-MM
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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