Medical Device

Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH

Recall date: 2026-06-24 · Source: FDA_DEVICE

Brand / Firm

Product

Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM NDL/AB-05060-PK; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/ASK-19609-VCU; CONTINUOUS NERVE BLOCK KIT/ASK-19600-CC2; CONTINUOUS NERVE BLOCK KIT 19 GA X 60/ASK-19608-CC; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-KP; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-SHC; FLEXBLOCK KIT:ECHO CATH, 17Gx8CM STM NDL/FB-19608-K; FLEXBLOCK ULTRASOUND KIT: 17Gx8CM STM ND/FB-19608-KU; FLEXBLOCK KIT:ECHO CATH, 17Gx9CM NS NDL/FB-19609-K; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/FB-19609-KU; CONTINUOUS PERIPHERAL NERVE BLOCK KIT/ASK-19608-US1; EPIDURAL CATHETERIZATION KIT/ASK-05001-SLR1; EPIDURAL CATHETERIZATION KIT/MH-05001; EPIDURAL CATHETERIZATION KIT/WJ-05401; SPINAL ANES/EPIDURAL CATH 19GA X 90CM/ASK-05501-USC1; EPIDURAL NEEDLE KIT/LG-03000; EPIDURAL ANESTHESIA KIT/MTO-03000-VM; EPIDURAL ANESTHESIA KIT/SM-03001; Anesthesia conduction kit/FB-19611-K

Reason for recall

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.

Units affected

205,685

Description

View official recall notice →