Reported Feb 4, 2015 · Terminated
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch…
Arrow International Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arrow International Inc · 2400 Bernville Road · Reading, PA · 19605
Is this the product you have?
- Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
- Lot codes and dates
- Product Codes
ASK-11142-MGH4ASK-04020-UR1CDC-45552-HPK1ACDC-35052-VPSASK-09903-MGH3CDC-02041-MK1ACDC-45041-VPSASK-09903-FAMCDC-05052-HPK1ANA-04020-X1ACDC-21242-X1AASK-04020-MIASK-04001-UOCMSO-45703-AHSCDC-45541-HPK1ACDC-35052-HPK1AASK-21142-SG1MSO-24703-AHSMSO-29802-AHSASK-12702-SMCCCDC-25142-X1A
- Lot Numbers
23F14H050123F14J028723F14J061923F14J139023F14H091823F14J061323F14J143323F14K011523F14J061723F14J035623F14K011423F14J055423F14J113423F14J155123F14J050823F14J114223F14J151623F14J135523F14H057723F14J023723F14H1120
- Product Codes
- Amount recalled
- 4484
Where it was sold
- Nationwide
- PR
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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