Recall record at a glance
| Official record | Z-0523-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Ecolab, Inc. |
| Report date | Feb 14, 2018 |
| Recall initiation date | Oct 13, 2017 |
| Quantity | 5,958 cases (50 per case) |
| Location | Saint Paul, MN, United States |
Official product description
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 Usage: Intended 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.
Why the product was recalled
Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
Distribution information
Distributed domestically to Michigan.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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