Recall Z-2274-2010
Arrow International Inc · initiated June 7, 2010
Product
Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801
Codes / lots: Lot numbers RF0018145, RF0021641, RF9044164, RF9069739, RF9070837, RF9100262
Reason for recall
Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed.
FDA-determined cause: Process change control
Action taken
June 7, 2010 Notification letter to customer instructed them to return the product to Arrow. Arrow will destroy the returned product.
Details
- Recall number
- Z-2274-2010
- Initiated
- June 7, 2010
- Posted by FDA
- August 25, 2010
- Terminated
- September 29, 2012
- Product code
- KGZ – Accessories, Catheter
- Quantity
- 3000 kits
- Distribution
- All affected product was distributed to one foreign consignee: Arrow Japan Ltd.
- Recalling firm
- Arrow International Inc, Reading, PA