TissueTech Recalls PROKERA Corneal Bandages Due to Microbial Contamination Risk
TissueTech, Inc. is recalling 63 units of PROKERA non-sterile biologic corneal bandages due to potential exposure to microbial contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of microbial contamination, which poses a significant health risk, but the source text does not report any confirmed illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
TissueTech, Inc. is recalling 63 units of PROKERA, non-sterile biologic corneal bandages. The recall was initiated because of a potential exposure of the product to microbial contamination.
The affected products were distributed nationwide in the United States, including in the states of FL, MN, NY, NC, SC, NJ, GA, PA, MD, DC, OH, WA, MI, CO, KS, TN, ME, AL, AR, TX, KY, MA, CA, CT, and OK. The specific lot codes involved are BTR192864, BTR194678, BTR192872, and BTR193024. The recall also covers specific serial IDs ranging from 20-PK16-00759 to 20-PK16-00821.
Consumers and healthcare providers should check their inventory for these specific lot and serial numbers. If the product is found, it should be removed from use and returned to the supplier or TissueTech, Inc. for further instructions.
The recalled product
- Product
- PROKERA, non-sterile - Product Usage: Biologic corneal bandage.
- Manufacturer
- TissueTech, Inc.
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 63
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Part of a larger recall action
This product is one of 3 recalled by TissueTech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · TissueTech, Inc.
See all →- HighTissueTech Recalls PROKERA Slim Corneal Bandages Due to Microbial Contamination
FDA (Devices) · 2020-12-16
- HighTissueTech Recalls PROKERA Plus Corneal Bandages Due to Microbial Contamination Risk
FDA (Devices) · 2020-12-16
Same hazard · microbial contamination
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