Z-1320-2009
Tri-State Centurion Laceration Tray - SnagFree, sterile, 16 per case, Tri-State Hospital Supply Corp...
Centurion Medical Products, LP / initiated 2009-01-14 / Terminated / root cause: packaging
Tri-State Hospital Supply Corporation began a recall of Tri-State Centurion Laceration Tray - SnagFree, sterile, 16 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder SUT12265 on . The reason FDA records is "Compromised sterility, as the package seals may be inadequate". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1320-2009
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Centurion Medical Products, LP
- Product
- Tri-State Centurion Laceration Tray - SnagFree, sterile, 16 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder SUT12265.
- Product code
- MCZ Suture Removal Kit
- Reason for recall
- Compromised sterility, as the package seals may be inadequate.
- Root cause tag
- packaging
- FDA root cause
- Packaging process control
- Action
- A letter titled "Urgent Product Recall Notice" was sent by Tri-State Hospital Supply Corporation to all consignees via certified mail titled dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand by sending the Accountability Information Form to the firm via fax (1-517-546-3356) or email and to hold the product for retrieval. Further questions should be addressed to Tri-State Hospital Supply Corp. at 1-517-546-5400 extension 1135.
- Quantity in commerce
- 288
- Distribution
- Nationwide including states of NC, FL, TX, NJ, IL, MA, GA and IA.
- Product codes and lots
- Lot Number: 2008111050.
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