Recall record at a glance
| Official record | Z-1057-2020 |
|---|---|
| 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-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING TRAY SUT10770 DEBRIDEMENT/SUTURE SET SUT10795 PORT IMPLANT SET SUT11035 SUTURE TRAY SUT11065 LACERATION TRAY SUT1113A SUTURING SET SUT11145 SNAGFREE SUTURE SET W/SURGICAL INST. SUT11515 LACERATION TRAY SUT11540A LACERATION TRAY SUT11590 SUTURE SET SUT11775 LACERATION TRAY SUT11780 MINOR TRAY SUT1189B LACERATION TRAY SUT11900 SUTURE TRAY SUT11910 LACERATION TRAY SUT11965 SUTURE SET SUT11970 SUTURE TRAY SUT12025 LACERATION TRAY SUT12225 SUTURE TRAY REGULAR SUT12275 SUTURING SET SUT12335 LACERATION TRAY SUT12625 SNAGFREE LACERATION TRAY SUT12765 SNAGFREE LACERATION TRAY SUT12895 SUTURE SET SUT12895 SUTURE SET SUT12895 SUTURE SET SUT12970 PLASTIC TRAY SUT13315 LACERATION TRAY SUT13400 SNAG FREE PLASTICS TRAY W/OR INSTRUMENTS SUT13510 LACERATION TRAY SUT13535 PLASTICS SUTURE TRAY SUT13550 LACERATION TRAY SUT13555 SUTURE TRAY SUT13620 LACERATION TRAY SUT13620 LACERATION TRAY SUT13720 LACERATION TRAY SUT13785 PLASTIC SUTURE TRAY SUT13830 LACERATION TRAY SUT13975 LACERATION TRAY SUT14000 ER SUTURE TRAY SUT14125 SUTURE SET W/SNAGFREE NEEDLEHOLDER SUT14125 SUTURE SET W/SNAGFREE NEEDLEHOLDER SUT14305 LACERATION TRAY SUT14355 SNAG FREE SUTURE TRAY SUT14370 ER FACIAL TRAY SUT14435 LACERATION TRAY W/ SAFETY NEEDLE SUT14655 LACERATION TRAY SUT14705 LACERATION TRAY SUT14730 MINOR SUTURE SET/ I&D TRAY SUT14730 MINOR SUTURE SET/ I&D TRAY SUT14800 NASAL SET SUT14805 TRACH SET SUT15085 LACERATION/INCISION & DRAINAGE TRAY SUT15140 LACERATION TRAY SUT15215 SNAG FREE LACERATION TRAY SUT15225 LACERATION TRAY SUT15255 LACERATION TRAY SUT15375 SUTURING SET SUT15390 SUTURE KIT SUT15430 ER SMALL SET SUT15525 SUTURE TRAY SUT15695 SUTURE SET SUT15735 SUTURE SET SUT15870 SUTURE SET SUT17015 SNAG FREE LACERATION TRAY SUT17015 SNAG FREE LACERATION TRAY SUT17080 RADIOLOGY LACERATION TRAY SUT17145 LACERATION TRAY SUT17155 LACERATION TRAY SUT17275 SUTURE SET SUT17500 SUTURE SET SUT17595 SNAGFREE LACERATION TRAY SUT17620 SUTURE TRAY SUT17620 SUTURE TRAY SUT17860 FINE PLASTICS TRAY SUT18150 LACERATION TRAY SUT18160 LACERATION TRAY SUT18160 LACERATION TRAY SUT18310 SNAGFREE LACERATION TRAY SUT18370 LACERATION TRAY SUT18425 TOENAIL EXCISION TRAY SUT18505 LACERATION TRAY SUT18510 SPECIALTY PLASTICS TRAY SUT18570 LACERATION TRAY SUT18655 FINE PLASTICS TRAY SUT18695 LACERATION TRAY SUT18765 LACERATION TRAY SUT18770 FINE PLASTIC SUTURE SET SUT18775 LACERATION TRAY SUT18810 SNAGFREE LACERATION TRAY SUT18890 LACERATION TRAY SUT18920 DR. DACEY SURGERY PACK SUT18920 DR. DACEY SURGERY PACK SUT18920 DR. DACEY SURGERY PACK SUT19050 LACERATION TRAY SUT19120 DERM SURGERY PACK SUT19170 TOENAIL KIT SUT19290A LACERATION TRAY SUT19340 LACERATION TRAY SUT19395 LACERATION TRAY SUT19450 SUTURE SET SUT19525 PLASTICS - PROCEDURE PACK SUT19615 PLASTICS SUTURE TRAY SUT19675 WOUND CLOSURE TRAY SUT19675 WOUND CLOSURE TRAY SUT20105 NAIL TRAY SUT20375 RECYCLABLE DERMATOLOGY MINOR SURGERY SET SUT20410 LACERATION TRAY SUT20410 LACERATION TRAY SUT20460 LACERATION TRAY SUT20500 LACERATION TRAY W/SNAGFREE NEEDLEHOLDER SUT20700 LACERATION TRAY SUT20745 LACERATION TRAY SUT20760 Wound Closure Tray SUT20780 CENTRAL LINE CATH KIT SUT20835 LACERATION TRAY SUT20965 LACERATION TRAY SUT20995 LACERATION TRAY SUT21010 DEBRIDEMENT TRAY SUT21015 PLASTIC SURGERY TRAY SUT21065 LACERATION TRAY SUT2220 LACERATION TRAY SUT2220 LACERATION TRAY SUT2750 SUTURING SET SUT2820 SUTURING SET SUT3100 FACIAL SUTURING SET SUT3780L LACERATION TRAY SUT5765 SUTURING SET SUT5765 SUTURING SET SUT6100 PLASTIC SUTURE GILLIES TRAY SUT6515 ST. JOSEPH ALL PURPOSE TRAY SUT6760 SUTURE TRAY SUT6960 CUSTOM LACERATION TRAY SUT6960 CUSTOM LACERATION TRAY SUT7980 LACERATION TRAY SUT8165 LACERATION TRAY SUT8295 LACERATION TRAY SUT8445 SATIN PLASTICS WOUND CLOSURE TRAY SUT8795 SUTURING SET SUT9005 SUTURING SET SUT9140
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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