Custom sterile surgical packs labeled as follows recall
Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
Why was Custom sterile surgical packs labeled as follows recalled?
DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers: 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, 46203903
- Product
- Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 181 units
- Distribution
- US Distribution to: NY
- Recall date
- February 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)