Recall record at a glance
| Official record | Z-1048-2020 |
|---|---|
| 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-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1183 AUXILARY TOWEL PACK DYNDA1223 CUSTOM PREP CUP KIT DYNDA1223 CUSTOM PREP CUP KIT DYNDA1246A CIRCUMCISION PACK DYNDA1349A CIRCUMCISION TRAY DYNDA1388 STERILE EK DOUBLE PACK DYNDA1615 STERILE BARRIER KIT DYNDA1615 STERILE BARRIER KIT DYNDA1628 VAG DELIVERY ACCESSORY PACK DYNDA1706A CIRCUMCISION TRAY W/OUT CLAMP DYNDA1843A DISPOSABLE SUTURE TRAY FGS DYNDA1843A DISPOSABLE SUTURE TRAY FGS DYNDA1861 IR KIT DYNDA1904 PREP TRAY DYNDA2076 VEIN PROCEDURE KIT DYNDA2201 SMALL BOWL KIT DYNDA2241 CIRCUMCISION TRAY DYNDA2271 CIRCUMCISION TRAY DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER DYNDA2418 MINOR PROCEDURE TRAY DYNDA2498 STERILE UNIVERSAL KIT
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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