DeRoyal Pelvic Exam Trays Recalled Due to Compromised Package Seals
DeRoyal Industries is recalling 3 packs of Pelvic Exam Trays because the outer package seals may be open or compromised, potentially affecting the sterility of the medical procedure packs.
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 a Class II medical device recall involving potential sterility compromise of surgical procedure packs. No illnesses or injuries have been reported. The hazard represents a risk-of-harm scenario (contamination of sterile medical instruments) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
DeRoyal Industries Inc is recalling 3 packs of Pelvic Exam Trays (REF 89-6219) distributed nationwide in the United States. The outer package seals on these procedure packs could be open or compromised, which may affect the sterility of the medical device inside.
Sterile medical procedure packs must maintain their protective seal to ensure the instruments and materials remain clean and free from contamination before use. Compromised seals can allow bacteria or other contaminants to enter the package, potentially making the contents unsafe for use in medical procedures.
Healthcare facilities and medical professionals who have received these recalled packs should identify any units with damaged, open, or compromised seals and immediately remove them from use. Contact DeRoyal Industries for further instructions on the recall and replacement of affected packs.
The recalled product
- Product
- Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 3
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 (4)
- a) REF 89-6219
- GTIN 50749756664382 (cs)
- 00749756664387 (unit)
- Lot Numbers: 58807114
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by DeRoyal Industries Inc 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.
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