FDAFDA · Food and drugs·Recall number Z-1030-2015
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
Published February 4, 2015 · Recall initiated: January 9, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arrow International Inc
- Distributor
- US (nationwide) and PR.
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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