ProgenaCare recalls progenamatrix Human Keratin Matrix, sterile, Rx, with the fo
Recalled Product
progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.
Hazard / Issue
Inner pouch seal may be inadequate resulting in lack of sterility.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: (1) Model PM2012, lot #02SEP21-001, exp. 4/9/2024; lot #29SEP21-001, exp. 4/9/2024. (2) Model PM3002, lot #28OCT21-001, exp. 3/7/2024. (3) Model PM3004, lot #02DEC21-001, exp. 10/1/2023; lot #02SEP21-002, exp. 10/1/2023; lot #14OCT21-001, exp. 10/1/2023; and 23NOV21-001, exp. 10/1/2023. (4) Model PM3006, lot #02SEP21-003, exp. 10/1/2023; lot #03DEC21-001, exp. 10/1/2023; lot #14OCT21-002, exp. 10/1/2023; and lot #23NOV21-002, exp. 10/1/2023. (5) Model PM3010, lot #13JUL21-001, exp. 10/1/2023; and lot #15JUL21-002, exp. 3/6/2024.
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