FDA-Device2023-01-18Class II
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
DeRoyal Industries Inc
Hazard
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.
Sold states
US Nationwide distribution in the states of IL, MO.
Affected count
157 packs
Manufactured in
200 Debusk Ln, Powell, TN, United States
Products
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0927-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief