CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report
MAC" Two-Lumen Central Venous Access Kit for use with 5 -. Catheters recalled
Arrow International is recalling MAC" Two-Lumen Central Venous Access Kit for use with 5 -. Catheters, distributed nationwide in the US. The recall was initiated on 11 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1916-2026
- FDA event ID
- 98618
- Recalling firm
- Arrow International, Morrisville, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Mar 2026
- FDA classified
- 22 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 11 Mar 2026 | Recall initiated by company | |
| 22 Apr 2026 | Classified by FDA | +42 days |
| 29 Apr 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Product as listed by the FDA
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 introduction to the central circulation.
Where it was distributed
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Nationwide ArizonaCaliforniaGeorgiaMassachusettsMaineMichiganOregonPennsylvaniaVirginia
Questions about this recall
Is MAC" Two-Lumen Central Venous Access Kit for use with 5 -. Catheters recalled?
Yes. Arrow International recalled MAC" Two-Lumen Central Venous Access Kit for use with 5 -. Catheters on 11 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-1916-2026.
Why was it recalled?
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Which lots are affected?
Product Code: ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 Batch Number: 33F25M0670
Where was it sold?
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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