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

    • 14224
    • 14225
    • 14226
    • 14237
    • 14238
    • 14239
    • 14240
    • 14255
    • 14253
    • 14254
    • 14252
    • 14261
    • 14266
    • 14260
    • 14265
    • 14262
    • 14279
    • 14276
    • 14269
    • 14275
    • 14273
    • 14258
    • 14274
    • 14281
    • 14286
    • 14287
    • 14283
    • 14282
    • 14288
    • 14272
    • 14280
    • 14289
    • 14308
    • 14307
    • 14309
    • 14310
    • 14311
    • 14337
    • 14342
    • 14335
    • 14338
    • 14345
    • 14346
    • 14336
    • 14343
    • 14339
    • 14344
    • 15015
    • 15013
    • 15019
    • 15020
    • 15021
    • 15022
    • 15030
    • 15029
    • 15028
    • 15033
    • 15036
    • 15037
    • 15035
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.

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 22, 2020 · Data as of Sep 19, 4:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.