Reported Jun 1, 2022 · Terminated
progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2…
ProgenaCare
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: ProgenaCare · 2275 Northwest Pkwy Se Ste 175 · Marietta, GA · 30067-9321
Is this the product you have?
- progenamatrix Human Keratin Matrix, sterile, Rx
- with the following model numbers
(1) PM201212 x 2 cm(2) PM30022 x 2 cm(3) PM30044 x 4 cmPM30066 x 6 cmand PM301010 x 10 cm
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Product as published PM2012(1) , lot #02SEP21-001, exp. 4/9/2024 PM3004lot #29SEP21-001, exp. 4/9/2024. (2) Model PM3002, lot #28OCT21-001, exp. 3/7/2024. (3) , lot #02DEC21-001, exp. 10/1/2023 — lot #02SEP21-002, exp. 10/1/2023 — lot #14OCT21-001, exp. 10/1/2023 PM3006and 23NOV21-001, exp. 10/1/2023. (4) , lot #02SEP21-003, exp. 10/1/2023 — lot #03DEC21-001, exp. 10/1/2023 — lot #14OCT21-002, exp. 10/1/2023 PM3010and lot #23NOV21-002, exp. 10/1/2023. (5) , lot #13JUL21-001, exp. 10/1/2023 — and lot #15JUL21-002, exp. 3/6/2024. - Amount recalled
- 547 packages
Where it was sold
Why it was recalled
Inner pouch seal may be inadequate resulting in lack of sterility.
This product could cause temporary or reversible health problems — stop using it.
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