Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYN...

FDA Recall #Z-1048-2020 — Class II — December 11, 2019

Recall #Z-1048-2020 Date: December 11, 2019 Classification: Class II Status: Terminated

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

Reason for Recall

Incomplete seals on the sterile package may compromise the sterility

Recalling Firm

Centurion Medical Products Corporation — Williamston, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

N/A

Distribution

Nationwide Foreign: GHANA

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

Browse All Device Recalls Device Recall Stats Device Safety Home
Back to All Device Recalls