[Recalled] Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product Code ASK-05502-NY — There is the potential for various failures with the LOR (loss of resistance) s… | FDA 2020-01-15

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Arrow International Inc

• Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42552 JX1A — Class II
• ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation. — Class II
• Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1 — Class II
• Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling — Class II
• 4Fr. Catheter Clamp with Fastener; Product Code: CC-00004 — Class II
• Radial Artery Catheterization Kit; Model: AK-04220 — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.