DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination
DeRoyal Industries is recalling 2,100 sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves unknown bioburden and particulate contamination in sterile medical kits, which poses a significant risk of infection or injury to patients.
Plain-English summary
DeRoyal Industries, Inc. is recalling 2,100 units of DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. The specific product affected is the ASC Laparoscopy Pack 89-6138.13. The recall is being conducted because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
The affected products were distributed in Rhode Island and New Jersey, specifically to the V.A Med Ctr East Orange. The recall involves catalog number 9541NA and lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, and 4418GSJ. The specific lot number for the ASC Laparoscopy Pack 89-6138.13 is 49505093, with an expiration date of 10/01/2023.
This recall is classified as Class II by the FDA. Consumers and healthcare facilities should stop using the affected products and contact DeRoyal Industries, Inc. for further instructions or a refund.
The recalled product
- Product
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
- Manufacturer
- Deroyal Industries, Inc. Lafollette
- Category
- Medical Device — Surgical Kits
- Affected units
- 2,100
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 (6)
- Catalog number 9541NA
- lot numbers 2708DJ1
- 3008DJ1
- 3008DSJ1 and 4418GSJ
- f. ASC Laparoscopy Pack 89-6138.13
- Lot number: 49505093 exp.10/01/2023
Distribution
Part of a larger recall action
This product is one of 10 recalled by Deroyal Industries, Inc. Lafollette under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
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