Medline Open Heart Peds Pack Convenience Kits Temperature Probe Recall
Medline Industries is recalling specific lots of Open Heart Peds Pack Convenience Kits containing Covidien Mon-a-Therm temperature probes due to a distribution control process error.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall. The source text states only that there was an error in a distribution control process, with no reported illnesses, injuries, or specific patient harm. This qualifies as a moderate-severity recall.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits (Open Heart Peds Pack, Model Numbers DYNJ88569, DYNJ88569A, DYNJ88569B, and DYNJ88569C) that contain Covidien Mon-a-Therm General Purpose Temperature Probes, Size 9 Fr. The recall affects 396 kits distributed nationwide.
The recall was initiated due to an error in Medtronic's distribution control process affecting specific production lots of the Covidien Mon-a-Therm general purpose temperature probe. The affected lot numbers are: 25ABO124, 24KBT583, 24KBB032, 25DBF217, 25JBP861, 26ABE456, and 25KBI025.
Customers who have received these kits should contact Medline Industries, LP for instructions on how to proceed. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B; 4) OPEN HEART PEDS PACK, Model Number: DYNJ88569C
- Manufacturer
- Medline Industries, LP
- Affected units
- 396
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 (20)
- 1) DYNJ88569
- UDI-DI: 10198459182334(each)
- 40198459182335(case)
- Lot Number: 25ABO124
- 2) DYNJ88569
- Lot Number: 24KBT583
- 3) DYNJ88569
- Lot Number: 24KBB032
- 4) DYNJ88569A
- UDI-DI: 10198459309649(each)
- 40198459309640(case)
- Lot Number: 25DBF217
- 5) DYNJ88569B
- UDI-DI: 10198459505669(each)
- 40198459505660(case)
- Lot Number: 25JBP861
- 6) DYNJ88569C
- UDI-DI: 10198459585876(each)
- 40198459585877(case)
- Lot Number: 26ABE456
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Medline Industries, LP 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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