DeRoyal Procedure Packs Recalled for Containing Recalled Steri Drapes
DeRoyal CRANI PACK procedure kits are being recalled because they contain 3M Health Care Steri Drapes that were previously recalled. Affected kits were distributed to medical facilities across multiple U.S. states.
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 an FDA Class II recall of medical device procedure kits containing a recalled component. While no illnesses or injuries are reported in this notice, surgical drapes are inherently risk-of-harm products used in medical procedures, and the recall status of the included component indicates an underlying defect or safety concern.
Plain-English summary
DeRoyal Industries Inc is recalling DeRoyal CRANI PACK procedure kits (Reference 89-10242.04, Lot 5688188, expiration 8/1/2023) because they contain 3M Health Care Steri Drapes that have been recalled.
The recalled procedure packs were distributed to medical facilities in the following U.S. states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.
The FDA has classified this as a Class II recall. Healthcare facilities and medical professionals who have received these kits should immediately cease using them and contact DeRoyal Industries Inc for guidance regarding returns or replacement product.
The recalled product
- Product
- DeRoyal CRANI PACK, REF 89-10242.04
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- recalled-component
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 (1)
- Lot Numbers: Lot 5688188 exp 8/1/2023
Distribution
Distribution scope not specified by the agency.
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