FDA Medical Device Recalls (openFDA)
Deroyal Industries, Inc. Lafollette: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
- Recall number
- Z-1415-2020
- Recalling firm
- Deroyal Industries, Inc. Lafollette
- Product
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
- Status
- Terminated
- Initiated
- 2020-02-04
- Posted
- 2020-02-19
- Terminated
- 2021-04-01
- Reason
- Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Root cause
- Environmental control
- Action
- DeRoyal issued their recall on 1/26/2020 to the end user level by sending recall letters to its direct accounts. The customers were asked to identify the affected products and return the provided notice of return form back to DeRoyal indicating if replacement or credit is requested.
- Quantity
- 2100 units
- Distribution
- US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
- Lot, serial or model codes
- Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; f. ASC Laparoscopy Pack 89-6138.13, Lot number: 49505093 exp.10/01/2023;
- 510(k) numbers
- ["K842648"]
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 3005011024
- Firm city
- La Follette
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28