Recall record at a glance
| Official record | Z-1042-2020 |
|---|---|
| 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 | 1986 |
| Location | Williamston, MI, United States |
Official product description
Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465 CIRCUMCISION TRAY CIT2470 CIRC TRAY W/UNIVERSAL CLAMP CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2510 CIRCUMCISION TRAY W/1.1 CM CLAMP CIT2530A CIRCUMCISION TRAY CIT2545 CIRCUMCISION TRAY CIT2630 CIRCUMCISION TRAY CIT2705 CIRCUMCISION TRAY CIT2730 CIRCUMCISION TRAY CIT3000 CIRCUMCISION TRAY CIT3010 CIRCUMCISION TRAY CIT3100 CIRCUMCISION TRAY CIT3145 UNIVERSAL CIRCUMCISION TRAY W/OUT CLAMP CIT3310 RECYCLABLE CIRCUMCISION TRAY CIT3315 CIRCUMCISION TRAY CIT3345 CIRCUMCISION TRAY CIT3465 L&D CIRCUMCISION SET CIT3690 CIRCUMCISION TRAY CIT3720 CIRCUMCISION TRAY CIT3725 CIRCUMCISION TRAY CIT3730 CIRCUMCISION TRAY CIT3800 CIRCUMCISION TRAY CIT3800 CIRCUMCISION TRAY CIT3835A UNIVERSAL CIRC TRAY W/SURGICAL INST CIT3865 CIRCUMCISION SET W/CLAMP AND 1.1 BELL CIT3890 CIRCUMCISION TRAY CIT4025 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4100 CIRCUMCISION TRAY - NO CLAMP CIT4100 CIRCUMCISION TRAY - NO CLAMP CIT4135 CIRCUMCISION TRAY CIT4140 CIRCUMCISION TRAY CIT4140 CIRCUMCISION TRAY CIT4180 CIRCUMCISION TRAY CIT4230 CIRCUMCISION TRAY CIT4260 CIRCUMCISION SET W/1.1 CLAMP CIT4335 CIRCUMCISION TRAY CIT4370 CIRCUMCISION TRAY CIT4400 CIRCUMCISION TRAY FOR CIRC CLAMP CIT4405 CIRCUMCISION TRAY FOR MOGEN CLAMP CIT4525 CIRCUMCISION TRAY CIT4775 CIRCUMCISION TRAY CIT4835 CIRCUMCISION TRAY WITH 1.3 CIRCLAMP CIT4840 CIRCUMCISION TRAY WITH 1.1 CIRCLAMP CIT4855 1.3 CIRCUMCISION TRAY CLAMP & BELL CIT5030 CIRCUMCISION TRAY CIT5135 UNIVERSAL CIRCUMCISION TRAY CIT5210 CIRCUMCISION TRAY CIT5290 UNIVERSAL CIRCUMCISION TRAY CIT5290 UNIVERSAL CIRCUMCISION TRAY CIT5295 CIRCUMCISION TRAY CIT5300 CIRCUMCISION TRAY CIT5340 CIRCUMCISION TRAY CIT5370 1.3 CIRCUMCISION TRAY CIT5375 CIRCUMCISION TRAY CIT5400 CIRCUMCISION TRAY CIT5460 UNIVERSAL CIRCUMCISION TRAY CIT5470 CIRCUMCISION TRAY W/1.1 BELL & CLAMP CIT5475 CIRCUMCISION TRAY CIT5495 CIRCUMCISION TRAY WITH UNIVERSAL CLAMP CIT5560 CIRC TRAY CIT5580 CIRCUMCISION KIT CIT5615 CIRCUMCISION TRAY CIT5615 CIRCUMCISION TRAY CIT5700 1.3 CIRCUMCISION KIT CIT5735 CIRCUMCISION TRAY CIT5745 CIRCUMCISION TRAY CIT5850 CIRCUMCISION TRAY CIT5955 CIRC TRAY WITH PVP AND SOFT STRAPS CIT6015 CIRCUMCISION TRAY CIT6050 CIRCUMCISION TRAY CIT6090 OSF CIRC TRAY WITH 1.1 CLAMP CIT6090 OSF CIRC TRAY WITH 1.1 CLAMP CIT6120 CIRCUMCISION TRAY CIT6200 CIRCUMCISION TRAY CIT6355 UNIVERSAL CIRCUMCISION TRAY CIT6365 CIRCUMCISION TRAY CIT6445 CIRCUMCISION TRAY CIT6545 CIRC TRAY CIT6560 CIRCUMCISION TRAY CIT6610A CIRCUMCISION TRAY NEWBORN NURSERY CIT6620 CIRCUMCISION TRAY CIT6635 CIRCUMCISION TRAY CIT6670 CIRCUMCISION TRAY CIT6685 CIRCUMCISION TRAY CIT6750 CIRCUMCISION TRAY CIT6860 CIRCUMCISION TRAY CIT6880 CIRCUMCISION TRAY CIT6920 NICU CIRCUMCISION TRAY W/OUT CLAMP CIT6935 CIRCUMCISION 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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