The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2382-2026·Announced 2026-06-24

Arrow drainage and thoracentesis kits contain recalled supplier drugs

Arrow drainage and thoracentesis kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 444,943 units are affected.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.

Plain-English summary

Arrow International is recalling drainage and thoracentesis kits, covering REF AK-01600, AK-01601, ASK-01601-MM, AK-01000-T, AK-01000, ASK-01000-CHP and ASK-01000-NW among the catalog numbers listed in the recall notice. The action covers 444,943 units.

Lidocaine, bupivacaine and 0.9% sodium chloride, the subject of a supplier recall, were included in the kits and sets. According to the manufacturer, the supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. The FDA classified the action as Class I, its most serious classification.

Distribution was nationwide in the United States across a large number of states. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the REF numbers, UDI-DI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Arrow International.

The recalled product

Product
Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-01000-CHP, DRAINAGE KIT/ASK-01000-NW, THORACENTESIS KIT/ASK-01000-UPMS, PNEUMOTHORAX KIT/AK-01500…
Manufacturer
ARROW INTERNATIONAL, LLC
Category
Medical Device — Drainage kit
Hazard
Affected units
444,943

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)

  • REF(Material)/UDI-DI/Lot(Batch): AK-01600/50801902120156
  • 10801902193275
  • 50801902120156
  • 60801902120160/33F24A0376
  • 33F24A1008
  • 33F24C0091
  • 33F24D0067
  • 33F24E0321
  • 33F24G0322
  • 33F24L0062
  • 33F24L0811
  • 33F24M0267
  • 33F25C0101
  • 33F25C0988
  • 33F25E0035
  • 33F25H0010
  • 33F25J0819
  • 33F26B0492
  • 33F24A0044
  • AK-01601/60801902120160

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 35 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.

See all 35 products in this recall →

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