Reported Apr 4, 2018 · Terminated
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult…
Covidien LLC
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: Covidien LLC · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
3 of 3 products
| Model / number | Barcodes | Product as published |
|---|---|---|
| — | Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator | |
10086042 | Battery | |
| — | 20884521700861 | UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost. |
- Lot codes and dates
- Serial Numbers1349MM0001
- UDI
2,714 of 2,714 codes
208845217008611349MM00021349MM00031349MM00041349MM00051349MM00061349MM00071349MM00081349MM00091349MM00101349MM00111349MM00121349MM00131349MM00141349MM00151349MM00161349MM00171349MM00181349MM00191349MM00201349MM00211349MM00221349MM00231349MM00241349MM00251349MM00261349MM00271349MM00281349MM00291349MM00301349MM00311349MM00321349MM00331349MM00341349MM00351349MM00361349MM00371349MM00381349MM00391349MM00401349MM00411349MM00421349MM00431349MM00441349MM00451349MM00461349MM00471349MM00481349MM00491349MM00501349MM00511349MM00521349MM00531349MM00541349MM00551349MM00561349MM00571349MM00581349MM00591349MM0060
- Amount recalled
- 15,885
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.
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.
Free recall alerts
Get alerted about new Covidien LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.