Sterile surgical kits: DeRoyal SELECTIVE ARTERIOGRAM PACK, REF 89-7284.02 Lot Number: 26166359; DeRoyal UNIVERSAL PACK,
FDA device recall Z-0963-2012 · posted 2012-02-06 · Terminated
Recall details
- Recalling firm
- DeRoyal Industries Inc
- Reason for recall
- Custom surgical kits contain recalled Kimberly Clark surgical drapes which were found to contain metal shavings in the folds of the drapes.
- Action taken
- DeRoyal Industries Inc. sent an "URGENT VOLUNTARY PRODUCT RECALL OF KIMBERLY-CLARK THREE-QUARTER DRAPE 79147" letter dated June 14, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify and quarantine all affected product. Further instructions by the firm asks customers to complete and return a Recall Response Spreadsheet via fax to 865-362-3744. Customers should contact their Deroyal Sales Representative for questions or assistance regarding this recall.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LRP
- Quantity affected
- 3881 kits
- Distribution
- Nationwide Distribution.
- Date initiated
- 2011-06-14
- Date posted
- 2012-02-06
- Date terminated
- 2013-06-27
- Location
- Powell, TN
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