Arrow Percutaneous Sheath Introducer Kit Recalled for Needlestick Injury Risk
Arrow International is recalling specific Percutaneous Sheath Introducer Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves reported needlestick injuries, which constitute significant injury reports, and the agency classification is Class II, meeting the criteria for a Severe rating.
Plain-English summary
Arrow International Inc. has initiated a recall of its Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, designed for use with 7 - 7.5 Fr. Catheters. 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 devices are identified by material number ASK-09801-ST. According to the firm, a total of 43,394 devices were distributed nationwide. The Arrow Percutaneous Sheath Introducer is a medical device used to permit venous access and catheter introduction to the central circulation.
Healthcare providers and facilities should stop using the affected kits immediately. Users should contact Arrow International Inc. for instructions on how to return the devices or obtain replacements. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5¿¿Fr. Catheters The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central ciruclation
- 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-09801-ST
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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