Recall record at a glance
| Official record | Z-1053-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Centurion Medical Products Corporation |
| Report date | Feb 12, 2020 |
| Recall initiation date | Dec 11, 2019 |
| Quantity | N/A |
| Location | Williamston, MI, United States |
Official product description
Centurion- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1223A LACERATION TRAY DYNDL1295B KIT,PAIN DYNDL1436A LACERATION TRAY DYNDL1436A LACERATION TRAY DYNDL1600B RCHSD CVP TRAY DYNDL1606A VAGINAL DELIVERY TRAY DYNDL1617A PICC INSERTION KIT-LATEX FREE DYNDL1617A PICC INSERTION KIT-LATEX FREE DYNDL1630A LACERATION TRAY DYNDL1675 ARTHROGRAM TRAY DYNDL1721 LACERATION TRAY DYNDL1721 LACERATION TRAY DYNDL1741A LACERATION TRAY DYNDL1744 LACERATION KIT DYNDL1755 LACERATION TRAY DYNDL1764A LACERATION TRAY DYNDL1772 LACERATION TRAY DYNDL1772 LACERATION TRAY DYNDL1786 SUTURING SET DYNDL1790 LACERATION TRAY DYNDL1796 LACERATION TRAY DYNDL1812 PEDI LACERATION TRAY DYNDL1840 SUTURE SET PACK DYNDL1847 ER SUTURE TRAY DYNDL1864A LACERATION TRAY DYNDL1897 LACERATION TRAY DYNDL1897 LACERATION TRAY DYNDL1920 LACERATION TRAY
Why the product was recalled
Incomplete seals on the sterile package may compromise the sterility
Distribution information
Nationwide Foreign: GHANA
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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