AbbVie Recalls 20 FR PEG Kits Due to Disconnection Reports
AbbVie is issuing an urgent field correction for 20 FR PEG Kits due to increased reports of tube disconnections from Y-connectors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect (disconnection) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AbbVie Inc. is issuing an urgent field correction notification for the AbbVie PEG Kit 20 FR. This action is being taken due to an increased number of reports indicating that the 20 FR PEG tube has disconnected from the Y-connectors.
The affected units include 541 kits with Product Code 62912-01-16 and specific lot numbers 32025245, 32265215, 32335206, and 32335336. These products were distributed to U.S. consignees located throughout the country and Puerto Rico, as well as to foreign consignees worldwide.
The source text does not specify the exact steps consumers or healthcare providers should take in response to this notification, nor does it report any specific injuries or illnesses resulting from the disconnections.
The recalled product
- Product
- AbbVie PEG Kit 20 FR
- Manufacturer
- AbbVie Inc.
- Affected units
- 541
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 (4)
- AbbVie PEG Kit 20 Fr Product Code 62912-01-16 with lot numbers: 32025245
- 32265215
- 32335206
- 32335336
Distribution
Distributed in 1 state:
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