Lubricating Jelly packaged as follows: (1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF 31-702, STERIL
FDA device recall Z-2013-2011 · posted 2011-04-18 · Terminated
Recall details
- Recalling firm
- DeRoyal Processing Center
- Reason for recall
- Possible contamination due to sterilization issue. Inspection of contract manufacturer found cGMP deficiencies.
- Action taken
- The firm notified their consignees by a Re: DeRoyal Recall Of Triad Group Lubricating Jelly letter, dated Friday, March 18,2011. The letter discussed the reason for recall and the affected products. The letter asked customers to identify inventory using the attached spreadsheet and quarantine to prevent further use. Customers are to complete the spreadsheet regardless if they have effected product or not. The completed form can be faxed to 865-362-3716 or emailed to recalls@deroyal.com. All affected products should be return to DeRoyal at the address provided. Distributors are to forward a copy of the notice to their end-users. If there are questions or assistance is needed with the recall, Stephanie DeBusk should be contacted at 865-362-1037 or Sharon Cook at 865-362-6157.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KMJ
- Quantity affected
- 323,440 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-02-07
- Date posted
- 2011-04-18
- Date terminated
- 2014-08-05
- Location
- New Tazewell, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUBRICATING JELLY (K871169) | H & P Industries, Inc. | 1987-04-01 |