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 involves a Class II medical device with reported needlestick injuries, which constitutes a significant injury report under the severity rubric.
Plain-English summary
Arrow International Inc. has initiated a nationwide recall of 43,394 units of the Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath. The specific product affected is identified by Material Number ASK-29803-MM. This medical device is designed for venous access and catheter introduction to the central circulation.
The recall was initiated due to reports of safety cover disengagement and needlestick injuries involving the BD Eclipse Needle, which is packaged with certain Arrow products. The source text does not specify the number of reported injuries or the specific dates of the incidents.
Healthcare facilities and consumers should stop using the affected Arrow Percutaneous Sheath Introducer Kits and contact Arrow International Inc. for further instructions on how to return or dispose of the product safely.
The recalled product
- Product
- Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis 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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