—#132965

Product

Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing

FDA product code: OBJ — Catheter, Ultrasound, Intravascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K121941, K122545
Affected lot / code info: Product Codes: ASK-11142-MGH4, ASK-04020-UR1, CDC-45552-HPK1A, CDC-35052-VPS, ASK-09903-MGH3, CDC-02041-MK1A , CDC-45041-VPS, ASK-09903-FAM, CDC-05052-HPK1A, NA-04020-X1A, CDC-21242-X1A, ASK-04020-MI, ASK-04001-UOC, MSO-45703-AHS, CDC-45541-HPK1A , CDC-35052-HPK1A, ASK-21142-SG1, MSO-24703-AHS, MSO-29802-AHS, ASK-12702-SMCC, CDC-25142-X1A; Lot Numbers: 23F14H0501, 23F14J0287, 23F14J0619, 23F14J1390, 23F14H0918, 23F14J0613, 23F14J1433, 23F14K0115, 23F14J0617, 23F14J0356, 23F14K0114, 23F14J0554, 23F14J1134, 23F14J1551, 23F14J0508, 23F14J1142, 23F14J1516, 23F14J1355, 23F14H0577, 23F14J0237, 23F14H1120

Why it was recalled

Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.

Root cause (FDA determination)

Packaging process control

Action the firm took

Arrow International, Inc. (Arrow) sent notification letters, dated January 9, 2015, to alert their direct account customers that it may be necessary to obtain an alternate Biopatch Dressing if a kit is used that contains an incorrectly sized Biopatch Dressing. Due to the inconvenience, Arrow will reimburse customers $7.50 per kit received.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: US (nationwide) and PR.

Timeline

Recall initiated: 2015-01-09
Posted by FDA: 2015-01-29
Terminated: 2017-08-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132965. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.