Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101358 LACERATION TRAY M101358 LACERATION TRAY M101358 LACERATION TRAY M101413 ADULT LUMBAR PUMP W NDLS MANO M101472A PREP PACK
This recall has been terminated (originally issued December 11, 2019).
- Recall Initiated
- December 11, 2019
- Terminated
- September 4, 2020
- Recall Number
- Z-1087-2020
- Firm Location
- Williamston, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Incomplete seals on the sterile package may compromise the sterility
Distribution
Nationwide Foreign: GHANA
Lot / Code Info
Product/Lot Code: M101156A DRESSING TRAY 2019041690 M101167A DRESSING TRAY 2018122190 M101168A DRESSING TRAY 2018122890 M101170A MAJOR DRESSING TRAY 2019040490 M101170A MAJOR DRESSING TRAY 2019021290 M101170A MAJOR DRESSING TRAY 2019020890 M101170A MAJOR DRESSING TRAY 2019012390 M101172B MINOR CORE DRESSING TRAY 2019041290 M101172B MINOR CORE DRESSING TRAY 2019030690 M101172B MINOR CORE DRESSING TRAY 2019020190 M101358 LACERATION TRAY 2019032290 M101358 LACERATION TRAY 2019021490 M101358 LACERATION TRAY 2019011890 M101413 ADULT LUMBAR PUMP W NDLS MANO 2019052190 M101472A PREP PACK 2019052990
Root Cause
Packaging process control
Action Taken
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.