Medline

Medline Industries is recalling three models of circumcision procedure kits because they contain lidocaine ampules with quality issues. The ampules were made by Huons Co., Ltd. and problems were found during an FDA manufacturing inspection. No injuries have been reported.

Medline's L&D Continuous Epidural Tray (Model PAIN1699A) contains Lidocaine Ampules that were recalled by the manufacturer, Huons Co., Ltd., due to quality problems found during an FDA inspection. About 432 kits with this component have been distributed nationwide.

Medline's Lumbar Puncture Choice Kit (Model DYNDH1215) contains Lidocaine Ampules manufactured by Huons Co., Ltd. that have quality issues identified during an FDA inspection of the manufacturer's facility. The affected kits were distributed nationwide.

Medline Industries is recalling two medical convenience kits that contain Lidocaine Ampules from Huons Co., Ltd. The Lidocaine was flagged for quality issues during an FDA inspection of the manufacturer's facility. About 250 kits were distributed nationwide.

Multiple Medline medical kits containing lidocaine ampules manufactured by Huons Co., Ltd. are being recalled due to quality issues found during an FDA inspection of Huons' manufacturing facility. The affected kits are used for various surgical and medical procedures including suturing, chest tube insertion, biopsies, and arterial line placement.

Medline Industries has recalled multiple medical procedure kits (central line, arterial line, dialysis, biopsy, and suturing kits) because they contain lidocaine ampules with quality issues. The lidocaine supplier, Huons Co., Ltd., issued a recall after the FDA inspected their manufacturing site and identified problems. No injuries have been reported.

Medline Convenience Kits (Model SUT13710) contain Lidocaine Ampules that were subject to a recall by the manufacturer Huons Co., Ltd. due to quality issues found during an FDA inspection of their manufacturing facility. About 176 kits were distributed nationwide.

Medline's Imaging Biopsy Tray (Model DYNDH1068) and Breast Biopsy Pack (Model PHS234706I) contain lidocaine ampules that were identified as defective during an FDA manufacturing inspection. The ampules were supplied by Huons Co., Ltd. and may not meet quality standards. Approximately 40 kits are affected nationwide.

Medline Convenience Kits containing Huons Lidocaine HCL Injection ampules are being recalled due to quality issues found during an FDA manufacturing inspection. The affected kits include two introducer models (6F and 9F) distributed nationwide. No injuries have been reported.

Medline Industries is recalling three models of medical convenience kits that contain Lidocaine Ampules manufactured by Huons Co., Ltd. The ampules were recalled due to quality issues found during an FDA inspection of the manufacturing facility. The affected kits are used in radiology, pain management, and endovenous procedures.

Medline is recalling 34 different models of central line insertion kits that contain lidocaine ampules manufactured by Huons Co., Ltd. The ampules were found to have quality issues during an FDA inspection of the manufacturer's facility. Approximately 967 kits are affected.

Medline's Convenience Kits (Model DYNJRA1590) contain Lidocaine Ampules that were recalled by the manufacturer, Huons Co., Ltd., due to quality issues found during an FDA manufacturing inspection. About 270 kits were distributed nationwide.

Medline distributed convenience kits containing lidocaine ampules manufactured by Huons Co., Ltd. The FDA identified quality issues with the lidocaine during a manufacturing inspection of Huons' facility. The affected kits are used for epidural anesthesia and pain management procedures.

Medline's arterial access and line insertion kits contain Lidocaine ampules from Huons Co., Ltd. that have quality defects. The defects were identified during an FDA inspection of the Lidocaine manufacturer's facility. The affected kits were distributed nationwide.

Medline Industries identified unapproved design changes to 10mL syringes in certain C-Section Tray convenience kits that were not cleared by the FDA under the original product authorization. The affected kits were distributed nationwide and to Barbados.

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were modified in ways that were not approved by the FDA. These design changes were not part of the original FDA clearance for these products. The kits are used in medical settings for procedures like central line insertion, vascular access, and fistula management.

Medline Industries identified unapproved design changes in certain 10mL polycarbonate colored syringes used in medical convenience kits. These changes were made outside the FDA-cleared design and were not originally reported to the FDA. The affected kits were distributed nationwide to healthcare facilities.

Medline Industries recalled over 113,000 convenience kits containing 10mL polycarbonate colored syringes used in cardiac and interventional radiology procedures. The firm made design changes to the syringes that were not approved by the FDA in the original product clearance. These kits were distributed nationwide.

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were modified with design changes that were not approved by the FDA. These kits are used in surgical and medical procedures including cataract surgery, vascular interventions, and spine procedures.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were modified in ways that were not approved by the FDA. The changes were made outside the scope of the FDA clearance originally granted for these products.

Medline Industries identified that certain 10mL polycarbonate colored syringes included in Major Basin Set convenience kits (model DYNJ85723) were modified in ways that were not approved by the FDA. These design changes were made outside of the FDA clearance process. Approximately 113,843 kits containing these syringes have been distributed nationwide.

Medline Industries identified that certain surgical convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The kits were distributed nationwide and include craniotomy, spine, laminectomy, and neuro packs used in operating rooms.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes used in neurological and angiography procedures contained design changes that were not reviewed or cleared by the FDA. These products were distributed nationwide and include multiple SKUs across neuro packs, angio packs, and related surgical kits.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The kits were sold nationwide and include various surgical and procedural trays used in hospitals and medical facilities.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The affected kits include Dr G's Breast Pack, Lipo Supplement Pack-LF, and Plastic Pack products distributed nationwide.

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Medline Industries identified that certain medical convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not reviewed or approved by the FDA. These kits are used in cardiac catheterization, angiography, and other medical procedures. The firm has initiated a recall of affected lots.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The affected kits include Angiogram Pack-LF and Judkins Pack models distributed nationwide.