Palindrome Chronic Catheter Kit recalls devices with incorrect length labeling
Covidien LP is recalling Palindrome Chronic Catheter Kit devices where some catheters labeled as 23 cm implant length actually contain 28 cm devices. The mislabeling could affect proper catheter placement.
What this means for you
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: This is a risk-of-harm product (dimensional mismatch in a chronic catheter) where no illnesses or injuries have been reported. While FDA Class II classification does not include hospitalization reports, the length discrepancy poses potential clinical risk if the incorrect length is used without verification.
Plain-English summary
Covidien LP is recalling the Palindrome Chronic Catheter Kit Symmetrical Tip (14.5 Fr/Ch, 4.8mm x 23cm) due to a labeling discrepancy. Some catheter kits labeled as having a 23 cm implant length contained catheters with a 28 cm implant length instead.
The recall affects 3,050 devices distributed worldwide, including throughout the US and 17 additional countries. The affected devices are identifiable by lot numbers 2221700131, 2224200233, 2230400271, and 2230400272, with UDI-DI codes 10884521013162 and 20884521013169.
The 5 cm difference in catheter length could affect proper device placement. The correct implant length can be identified by examining the labeling on the catheter body itself.
The recalled product
- Product
- Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
- Manufacturer
- Covidien LP
- Hazard
- mis-labeling
- length-mismatch
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 (6)
- UDI-DI: 10884521013162
- 20884521013169
- Lot Numbers: 2221700131
- 2224200233
- 2230400271
- 2230400272
Distribution
Distributed nationwide across the United States.
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