Reported Jan 18, 2023 · Terminated
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
- DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
- Lot codes and dates
a) REF 89-9004.09GTIN 00749756903936
- Lot Numbers
57391129 exp 5/1/202357755421 exp 5/1/202357900931 exp 5/1/2023 b) REF 89-9004.10GTIN 00749756903931
- Lot Numbers57913767 exp 5/1/2023
- Amount recalled
- 157 packs
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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