Recall record at a glance
| Official record | Z-1650-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Smiths Medical ASD, Inc. |
| Report date | May 28, 2014 |
| Recall initiation date | Apr 22, 2014 |
| Quantity | 2120 devices |
| Location | Rockland, MA, United States |
Official product description
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures.
Why the product was recalled
The hose could separate from the blanket.
Distribution information
Worldwide Distribution Including the States of CA, IL, KY, MS, NC, TN, TX, WA, WI and the Countries of BH, DE, NO, RU
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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