DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
FDA device recall Z-0927-2023 · posted 2023-01-09 · Terminated
Recall details
- Recalling firm
- DeRoyal Industries Inc
- Reason for recall
- DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
- Action taken
- DeRoyal sent an urgent recall notice to its consignees on 12/12/2022 by email and they followed with a letter sent overnight to the end user. The notice explained the problem and the hazard, and requested the following actions be taken: "1) Using the attached Affected Products Listing, identify affected surgical pack numbers in your inventory and place in quarantine to prevent further use. Please return the packs that you have in inventory to us. You will be given credit or replacement for the returned product. 2) Complete the NOTICE OF RETURN FORM, indicating all affected products found in your inventory. Please return the completed form to DeRoyal via fax to 865-362-3716 or recalls@deroyal.com no later than January 15, 2023. 3) If you have questions regarding credit for the recall, please contact Jennifer Marsh at jmarsh@deroyal.com or by phone 865-362-4203 or email us at recalls@deroyal.com. 4) PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 5) If you have further distributed these products, it is required by federal law that your customers be notified of this recall. You may either do this directly by forwarding our recall notification and notify us that you have done so, or you may provide us with your customer listing and we will contact them."
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 157 packs
- Distribution
- US Nationwide distribution in the states of IL, MO.
- Date initiated
- 2022-12-12
- Date posted
- 2023-01-09
- Date terminated
- 2026-05-29
- Location
- Powell, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENERAL SURGERY TRAY (K842648) | Deroyal Industries, Inc. | 1984-09-20 |