ARROW IPN029646Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

11 other recalls cover devices cleared under the same FDA submission (K820009); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. 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.

   Z-2368-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. 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.

   Z-2391-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K820009. One submission often covers many models, so check the product and lot details in each record.

• Z-2377-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSE
• Z-1243-2020 · Dec 20, 2019 · Terminated
  Arrow Central Venous Catheterization Kit ASK-04200-UPM
• Z-1974-2018 · Apr 11, 2018 · Terminated
  Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ
• Z-1331-2018 · Dec 22, 2017 · Terminated
  (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) V
• Z-2328-2017 · May 9, 2017 · Terminated
  Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulati
• Z-1347-2011 · Oct 29, 2010 · Terminated
  VESSEL CATHETERIZATION KIT/Product SKU's (Codes) AK-04550, AK-4550-A and ASK-04550-TG. Vessel catheterization kit
• Z-1348-2011 · Oct 29, 2010 · Terminated
  CENTRAL VENOUS CATHETERIZATION KIT/Product SKU's (Codes) AK-04650-E and AK-04660. Central venous catheterization kit
• Z-1345-2011 · Oct 29, 2010 · Terminated
  PEDIATRIC JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04150-E Pediatric jugular puncture kit
• Z-1344-2011 · Oct 29, 2010 · Terminated
  INTERNAL JUGULAR PUNCTURE KIT with Blue FlexTip(R) Catheter/Product SKU (Code) AK-04050 Internal jugular puncture kit
• Z-1349-2011 · Oct 29, 2010 · Terminated
  JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04800. Jugular puncture kit
• Z-1494-2009 · Feb 11, 2009 · Terminated
  Arrow Single Lumen CVCs (Central Venous Catheters)