DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Reported: January 18, 2023 Initiated: December 12, 2022 #Z-0927-2023
Product Description
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
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.
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 157 packs
- Distribution
- US Nationwide distribution in the states of IL, MO.
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10. Recalled by DeRoyal Industries Inc. Units affected: 157 packs.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2023. Severity: Moderate. Recall number: Z-0927-2023.
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