DeRoyal and GEO-MED sterile surgical kits recalled for seal defects
DeRoyal Industries is recalling 836 sterile custom surgical kits because a component may have packaging seal defects that compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a potential sterility breach in surgical kits, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
DeRoyal Industries Inc is recalling 836 units of sterile custom surgical kits, including Emergency CABG Packs, Open Heart Packs, and Intl-Cardiac Surgery Packs. The recall involves specific DeRoyal and GEO-MED product references and lot numbers. These kits were distributed in Missouri, Massachusetts, North Carolina, Connecticut, and Kuwait.
The recall was initiated because the kits contain the component ECOLAB ORS Fluid Warming and Slush Drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch. This defect could potentially compromise the sterility of the surgical kits.
Healthcare facilities and consumers who have these specific products should stop using them and contact DeRoyal Industries Inc for further instructions. The agency has classified this as a Class II recall.
The recalled product
- Product
- DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02…
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 836
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 (20)
- Ref 89-7859.01: Lot numbers: 27369748
- 27469087
- 27964707
- 28167081
- 28207599
- 28712544
- Ref 89-7859.02: Lot numbers: 35947501
- 35550352
- 38844461 Ref 89-7750.02: Lot numbers: 29929171
- 30474952 Ref 89-7750.03: Lot numbers: 30984021
- 31210924 Ref 89-8514.02: Lot numbers: 37392319
- 37078506
- 37109721
- 36974376
- 37057289
- 36813530
- 37086725
- 37099609
- 37253124
- 37325378
Distribution
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