Recall record at a glance
| Official record | Z-0145-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Parker Laboratories, Inc. |
| Report date | Nov 5, 2014 |
| Recall initiation date | Aug 6, 2014 |
| Quantity | 367 boxes |
| Location | Fairfield, NJ, United States |
Official product description
Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.
Why the product was recalled
Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the Eclipse Probe Covers.
Distribution information
Worldwide Distribution: US (Nationwide) and country of: Canada.
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: Telephone.
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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