DeRoyal sterile custom surgical kits: 1) Emergency CABG recall
DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B…
Why was DeRoyal sterile custom surgical kits: 1) Emergency CABG recalled?
These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch.
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?
Ref 89-7859.01: Lot numbers: 27369748, 27469087, 27964707, 28167081, 28207599, 28712544; Ref 89-7859.02: Lot numbers: 35947501, 35550352, 38844461 Ref 89-7750.02: Lot numbers: 29929171, 30474952 Ref 89-7750.03: Lot numbers: 30984021, 31210924 Ref 89-8514.02: Lot numbers: 37392319, 37078506, 37109721, 36974376, 37057289, 36813530, 37086725, 37099609, 37253124, 37325378, 37401318, 37413132 Ref 89-5792.10: Lot numbers: 39821181, 39507167, 39072116, 39863866 Ref 89-7626.02: Lot numbers: 36068496, 359097163, 35543822, 35328356, 35428242, 35549693, 34939471, 33091009, 34952712 Ref 89-7626.03: Lot numbers: 39301960, 36660692, 37008882, 37210095, 37915491, 37217991, 40101164, 37519742, 38455852, 38756495, 39417057, 39714051, 39913835 Ref 89-8440.01: Lot numbers: 36674648, 36612412 Ref 89-8440.02: Lot number: 36987476
- Product
- DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B…
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 836 units
- Distribution
- Distributed in MO, MA, NC, CT, Kuwait.
- Recall date
- December 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)