High FDA (Devices)·Z-1329-2018·Announced 2018-04-18

Arrow International Recalls Certain Percutaneous Sheath Introducer Kits Due to Sterility Concerns

Arrow International Inc is recalling certain lots of percutaneous sheath introducer kits because they may not be completely sealed, meaning sterility cannot be guaranteed.

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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (loss of sterility) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Arrow International Inc is recalling certain lots of percutaneous sheath introducer kits. The recall is being conducted because the cardiovascular catheters in these kits may not be completely sealed, which means the sterility of the product cannot be guaranteed.

The affected products include various models of percutaneous sheath introducer kits designed for use with 7.5 - 8 Fr. catheters. Specific part numbers involved in the recall include ASK-09803-WBH1, ASK-09903-KH, ASK-09903-LC, ASK-09903-PHP, ASK-09907-LGH1, CDC-09803-1A, and CDC-09903-1A. The recall covers specific lot numbers, including 13F17C0208, 13F17F0162, 13F17F0231, 13F17E0382, 13F17F0206, 13F17D0049, 13F17A0052, 13F17C0390, 13F17A0123, 13F17E0014, 13F17E0455, 13F17F0289, 13F16M0274, 13F17E0040, 13F17E0227, and 13F17E0824.

These products were distributed in all 50 U.S. states and the District of Columbia, as well as in the Bahamas, Canada, Mexico, Panama, and Singapore. Healthcare providers and facilities should check their inventory for these specific part numbers and lot numbers. If the affected products are found, they should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.

The recalled product

Product: (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1; (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Po
Manufacturer: Arrow International Inc
Category: Medical Device — Cardiovascular Catheters
Hazard: sterility-compromise

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 (16)

Lot Numbers: (1) 13F17C0208
13F17F0162
(2) 13F17F0231
(3) 13F17E0382
13F17F0206
(4) 13F17D0049
(5) 13F17A0052
13F17C0390
(6) 13F17A0123
13F17E0014
13F17E0455
13F17F0289
(7) 13F16M0274
13F17E0040
13F17E0227
13F17E0824

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 14 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.

See all 14 products in this recall →

Same manufacturer · Arrow International Inc

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Same hazard · sterility compromise