—#178555

Product

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

FDA product code: LRP — Tray, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Numbers: DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 2019031990 DYNDA1178 ICIO TRAY 2019050690 DYNDA1183 AUXILARY TOWEL PACK 2018100390 DYNDA1223 CUSTOM PREP CUP KIT 2019031290 DYNDA1223 CUSTOM PREP CUP KIT 2019021490 DYNDA1246A CIRCUMCISION PACK 2018111290 DYNDA1349A CIRCUMCISION TRAY 2019030190 DYNDA1388 STERILE EK DOUBLE PACK 2019030890 DYNDA1615 STERILE BARRIER KIT 2019031590 DYNDA1615 STERILE BARRIER KIT 2019012390 DYNDA1628 VAG DELIVERY ACCESSORY PACK 2019040290 DYNDA1706A CIRCUMCISION TRAY W/OUT CLAMP 2019031290 DYNDA1843A DISPOSABLE SUTURE TRAY FGS 2019061090 DYNDA1843A DISPOSABLE SUTURE TRAY FGS 2019030190 DYNDA1861 IR KIT 2019022590 DYNDA1904 PREP TRAY 2019011590 DYNDA2076 VEIN PROCEDURE KIT 2018101590 DYNDA2201 SMALL BOWL KIT 2019022690 DYNDA2241 CIRCUMCISION TRAY 2019032590 DYNDA2271 CIRCUMCISION TRAY 2019031990 DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER 2019050690 DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER 2019030590 DYNDA2418 MINOR PROCEDURE TRAY 2019021390 DYNDA2498 STERILE UNIVERSAL KIT 2019061190

Why it was recalled

Incomplete seals on the sterile package may compromise the sterility

Root cause (FDA determination)

Packaging process control

Action the firm took

Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: Nationwide Foreign: GHANA

Timeline

Recall initiated: 2019-12-11
Terminated: 2020-09-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178555. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.