Reported Dec 16, 2020 · Terminated
PROKERA, non-sterile - Product Usage: Biologic corneal bandage.
TissueTech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: TissueTech, Inc. · 8305 NW 27th St Ste 101 · Doral, FL · 33122-1934
Is this the product you have?
- PROKERA
- non-sterile - Product UsageBiologic corneal bandage
- Lot codes and dates
- Lot Codes
BTR192864BTR194678BTR192872
- BTR193024 Serial ID
63 of 63 codes
20-PK16-0076120-PK16-0076220-PK16-0076320-PK16-0076720-PK16-0079620-PK16-0079720-PK16-0079820-PK16-0080320-PK16-0081520-PK16-0081620-PK16-0081720-PK16-0081820-PK16-0081920-PK16-0075920-PK16-0076020-PK16-0080820-PK16-0080920-PK16-0078120-PK16-0082020-PK16-0079120-PK16-0079220-PK16-0080420-PK16-0080520-PK16-0080620-PK16-0080720-PK16-0081020-PK16-0081120-PK16-0081220-PK16-0081320-PK16-0081420-PK16-0076820-PK16-0076920-PK16-0078220-PK16-0078320-PK16-0077820-PK16-0077020-PK16-0077120-PK16-0077220-PK16-0077320-PK16-0077420-PK16-0077520-PK16-0077620-PK16-0077720-PK16-0076520-PK16-0077920-PK16-0078020-PK16-0079920-PK16-0080020-PK16-0079320-PK16-0079420-PK16-0079520-PK16-0078420-PK16-0078520-PK16-0080120-PK16-0076420-PK16-0082120-PK16-0078920-PK16-0079020-PK16-0076620-PK16-00786
- Lot Codes
- Amount recalled
- 63 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Potential exposure of product to microbial contamination.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new TissueTech, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.