medical Class II Updated 2020-12-16

TissueTech, Inc. recalls PROKERA, non-sterile - Product Usage: Biologic corneal banda

Recalled Product

PROKERA, non-sterile - Product Usage: Biologic corneal bandage.


Hazard / Issue

Potential exposure of product to microbial contamination.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Codes: BTR192864, BTR194678, BTR192872, BTR193024 Serial ID: 20-PK16-00761,20-PK16-00762,20-PK16-00763,20-PK16-00767,20-PK16-00796,20-PK16-00797,20-PK16-00798,20-PK16-00803,20-PK16-00815,20-PK16-00816,20-PK16-00817,20-PK16-00818,20-PK16-00819,20-PK16-00759,20-PK16-00760,20-PK16-00808,20-PK16-00809,20-PK16-00781,20-PK16-00820,20-PK16-00791,20-PK16-00792,20-PK16-00804,20-PK16-00805,20-PK16-00806,20-PK16-00807,20-PK16-00810,20-PK16-00811,20-PK16-00812,20-PK16-00813,20-PK16-00814,20-PK16-00768,20-PK16-00769,20-PK16-00782,20-PK16-00783,20-PK16-00778,20-PK16-00770,20-PK16-00771,20-PK16-00772,20-PK16-00773,20-PK16-00774,20-PK16-00775,20-PK16-00776,20-PK16-00777,20-PK16-00765,20-PK16-00779,20-PK16-00780,20-PK16-00799,20-PK16-00800,20-PK16-00793,20-PK16-00794,20-PK16-00795,20-PK16-00784,20-PK16-00785,20-PK16-00801,20-PK16-00764,20-PK16-00821,20-PK16-00789,20-PK16-00790,20-PK16-00766,20-PK16-00786,20-PK16-00787,20-PK16-00788, and 20-PK16-00802
View official government recall

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