DeRoyal (R) Incision and Drainage Tray, RES 47-763.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 D
FDA device recall Z-2891-2011 · posted 2011-07-28 · Terminated
Recall details
- Recalling firm
- Deroyal Industries, Inc. Lafollette
- Reason for recall
- Custom surgical kits contain recalled Triad PVP prep pads
- Action taken
- DeRoyal sent a Customer letter dated July 6, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to reference the attached spreadsheet to identify your accounts kits/trays and the corresponding lot numbers affected by this recall. Please complete and return the Acknowledgement Form by fax ( 865-362-3716) confirming you have been notified of this action. For further questions, please call ( 865) 362-2334.
- Root cause
- Other
- Status
- Terminated
- Product code
- LRP
- Quantity affected
- 11,856 kits/trays
- Distribution
- Nationwide Distribution--including the states of CA, FL,GA, HI, IL, IN, LA, MA, MO, MS, NY, PA, and RI.
- Date initiated
- 2011-04-28
- Date posted
- 2011-07-28
- Date terminated
- 2014-08-07
- Location
- La Follette, TN
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