HEMASHIELD Knitted Double Velour Cardiovascular Fabric
This recall has been terminated (originally issued March 20, 2018).
- Company
- Getinge Us Sales Llc
- Recall Initiated
- January 3, 2018
- Posted
- March 20, 2018
- Terminated
- July 3, 2018
- Recall Number
- Z-1172-2018
- Quantity
- 1
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).
Distribution
FL
Lot / Code Info
UDI code: 00384401017899 Catalog number: M002000195140 Lot number: 16M21 Serial number: 1092238229
Root Cause
Labeling mix-ups
Action Taken
On January 3, 2018 an URGENT MEDICAL DEVICE RECALL NOTICE was issued to the (1) affected customer. A return authorization was issued with the recall letter, which is intended to be returned to the recalling firm. Questions or concerns can be directed to 1-800-528-7486
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