Skip to main content
High RiskFDA
Arrow International Inc
Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product Code ASK-05502-NY
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Abbott Point Of Care Inc.
i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the q...
Medical Devices·99,850 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code EC-05520-P
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Cardinal Health 200, Llc
Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of flui...
Medical Devices·8,000 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code DE-05400D-BO
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIP
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501
Medical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Cardinal Health 200, Llc
Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection ...
Medical Devices·8,400 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code BE-05400B-ETTEL
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-12
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-CHH
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code MTO-05500-SU
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Bard Peripheral Vascular Inc
BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen V...
Medical Implants·200 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Abbott Point Of Care Inc.
i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for ...
Diabetes Devices·9,049,725 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-05520-EPI
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Cardinal Health 200, Llc
Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of flu...
Medical Devices·0 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Pharmaceutical Associates Inc
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, ...
Oral Drugs·6,288 affected·Jan 14, 2020
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed ...
Injectable Drugs·0 affected·Jan 14, 2020
High RiskFDA
Spectrum Laboratory Products
Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 gra...
Drugs·0 affected·Jan 14, 2020
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose V...
Injectable Drugs·0 affected·Jan 14, 2020
High RiskFDA
Ormco/sybronendo
Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, T...
Medical Devices·2,189 affected·Jan 14, 2020
High RiskFDA
Cme America, Llc
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is int...
Medical Devices·5,800 affected·Jan 14, 2020