Reported Dec 9, 2015 · Terminated
DeRoyal sterile custom surgical kits
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
20 of 20 products
| Model / number | Product as published |
|---|---|
89-7859.01 | — |
| — | Lot numbers: 27369748, 27469087, 27964707, 28167081, 28207599, 28712544 |
89-7859.02 | — |
| — | Lot numbers: 35947501, 35550352, 38844461 |
89-7750.02 | — |
| — | Lot numbers: 29929171, 30474952 |
89-7750.03 | — |
| — | Lot numbers: 30984021, 31210924 |
89-8514.02 | — |
| — | Lot numbers: 37392319, 37078506, 37109721, 36974376, 37057289, 36813530, 37086725, 37099609, 37253124, 37325378, 37401318, 37413132 |
89-5792.10 | — |
| — | Lot numbers: 39821181, 39507167, 39072116, 39863866 |
89-7626.02 | — |
| — | Lot numbers: 36068496, 359097163, 35543822, 35328356, 35428242, 35549693, 34939471, 33091009, 34952712 |
89-7626.03 | — |
| — | Lot numbers: 39301960, 36660692, 37008882, 37210095, 37915491, 37217991, 40101164, 37519742, 38455852, 38756495, 39417057, 39714051, 39913835 |
89-8440.01 | — |
| — | Lot numbers: 36674648, 36612412 |
89-8440.02 | — |
| — | Lot number: 36987476 |
- Amount recalled
- 836 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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