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.
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 2/5 (Moderate).
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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