Reported Feb 14, 2018 · Terminated
Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches…
Ecolab, 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: Ecolab, Inc. · 940 Lone Oak Rd · Saint Paul, MN · 55121-2214
Is this the product you have?
- Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box
- Product UsageIntended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. Single use device
- Lot codes and dates
- Model/Item/Part No. B1-715-65
- Lot Numbers
276 of 276 codes
142241422514226142371423814239142401425514253142541425214261142661426014265142621427914276142691427514273142581427414281142861428714283142821428814272142801428914308143071430914310143111433714342143351433814345143461433614343143391434415015150131501915020150211502215030150291502815033150361503715035
- Amount recalled
- 5,958 cases (50 per case)
Where it was sold
Why it was recalled
Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
This product could cause temporary or reversible health problems — stop using it.
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