Puritan Bennett 980 Series Ventilator recalled for capacitor assembly error
The Puritan Bennett 980 Series Ventilator is being recalled because a capacitor may be assembled incorrectly, which could cause the ventilator to stop working during use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls score at minimum 4 (Severe). No deaths or serious injuries have been reported in the source text.
Plain-English summary
The Puritan Bennett 980 Series Ventilator (model 980A1ENNISB) is subject to a Class I recall by the U.S. Food and Drug Administration due to a manufacturing assembly error.
A capacitor within the ventilator may be assembled incorrectly, which could cause the device to become inoperable during use.
Approximately 278 affected units have been distributed worldwide, including to US locations. Specific serial numbers are provided in the FDA recall notice.
Facilities and individuals using this model should verify their device serial number against the recall list. If your device matches an affected serial number, contact the manufacturer Covidien Llc for instructions regarding replacement or repair.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980A1ENNISB
- Manufacturer
- Covidien Llc
- Affected units
- 278
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- GTIN/UDI - 10884521201897 Serial Numbers: 35B1700507
- 35B1700533
- 35B1700539
- 35B1700465
- 35B1700580
- 35B1700530
- 35B17005363
- 5B1700542
- 35B1700509
- 35B1701614
- 35B1700527
- 35B1700537
- 35B1700541
- 35B1700508 & 35B1701569.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Covidien Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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