Recall record at a glance
| Official record | Z-0749-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | GE Healthcare, LLC |
| Report date | Feb 20, 2013 |
| Recall initiation date | Oct 15, 2012 |
| Quantity | 276 units total, 109 of those nationwide. |
| Location | Waukesha, WI, United States |
Official product description
Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
Why the product was recalled
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Distribution information
Worldwide Distribution - Worldwide Distribution - USA including AL, AZ, CA, CO, FL,GA, IA, ID, IL, KY, MA, MD, MI, MN, MO, MS, MT, NC, ND ,NE, NM, NV, NY, OH, OR, PA ,TX, VT, WA, WI and WV; and the countries of Australia, Belgium, Canada, China, France, New Zealand, Poland, Saudi Arabia, Switzerland and United Kingdom.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement 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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