MAC two-lumen central venous kits recalled over incorrectly manufactured adhesive
The MAC Two-Lumen Central Venous Access Kit is being recalled after a supplier notified the firm that the liquid adhesive used in the device was incorrectly manufactured.
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: FDA Class II recall of a central venous access device built with incorrectly manufactured adhesive, a risk of harm with no injuries reported in the source.
Plain-English summary
The MAC Two-Lumen Central Venous Access Kit for use with 7.5-8 Fr catheters, REF ASK-11142-LC2, batch 33F25M0670, is being recalled. The device permits short-term venous access of under 30 days and catheter introduction to the central circulation. The action covers 90 units.
The recall follows a notice from a supplier that the liquid adhesive used in the device was incorrectly manufactured. The FDA classified the action as Class II.
Distribution was within the United States, in Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania and Virginia. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the product code, UDI and batch number above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter…
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 90
Distribution
Part of a larger recall action
This product is one of 8 recalled by ARROW INTERNATIONAL, LLC 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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