Central Venous Catheter Kits Recalled for Potential Temperature Damage
McKesson Medical-Surgical is recalling Teleflex Arrow Central Venous Catheter Kits due to temperature excursions during storage and shipment. Exposure to higher temperatures may have reduced product effectiveness.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is temperature-induced potential loss of device effectiveness, which is theoretical rather than confirmed. Per the severity rubric, recalls with theoretical hazards and no reported harm score at most 3 (High).
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Teleflex Arrow Central Venous Catheter Kits (Model CDC-45703-XP1A) due to temperature excursions that occurred between June and August 2021 prior to delivery. Exposure to higher temperatures may have impacted product effectiveness.
The affected devices are 16 and 18 gauge multi-lumen central venous catheters distributed nationwide. All products received between June 1, 2021, and September 30, 2021, may be affected. Central venous catheters are medical devices used to deliver medications and fluids into patients' veins.
For additional information and instructions, refer to the FDA recall notice (Z-1604-2022).
The recalled product
- Product
- TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 5
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 (3)
- GTIN: 30801902058615
- 00801902058614
- 20801902058618
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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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