DeRoyal surgical procedure pack recalled for sterile barrier defect
DeRoyal is recalling certain surgical procedure packs containing Medtronic non-absorbable sutures due to a manufacturing error that may breach the sterile barrier protecting the surgical field.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall with no reported illnesses or injuries. The defect creates a potential sterile barrier breach in a surgical device—a risk-of-harm product—but the harm is theoretical rather than reported. Per the rubric, such cases score 3 (High).
Plain-English summary
DeRoyal Industries Inc is recalling specific lots of its ORGAN RECOVERY PACK PGYBK surgical procedure packs due to a manufacturing error in Medtronic non-absorbable sutures. The defect may cause a gap or wrinkle in the breather seal, potentially compromising the sterile barrier of the surgical pack.
The recall affects 157 packs that were distributed in Illinois and Missouri. Affected products include two references: REF 89-9004.09 with lot numbers 57391129, 57755421, and 57900931, and REF 89-9004.10 with lot number 57913767. All affected lots expire on May 1, 2023.
Healthcare facilities that have received these products should verify their inventory against the affected lot and reference numbers. If affected packs are identified, facilities should contact DeRoyal Industries Inc for additional guidance.
The recalled product
- Product
- DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 157
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- a) REF 89-9004.09
- GTIN 00749756903936
- Lot Numbers: 57391129 exp 5/1/2023
- 57755421 exp 5/1/2023
- 57900931 exp 5/1/2023 b) REF 89-9004.10
- GTIN 00749756903931
- Lot Numbers: 57913767 exp 5/1/2023
Distribution
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