FDAJune 15, 2017device
Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
What to do
FDA enforcement status: Terminated
Brands named
custom assembliescustom
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- USDA FSISCustom Food Solutions Recalls Ready-To-Eat Frozen Drunken Chicken Product Due to Misbranding and Undeclared Allergens2025-01-22
- FDAJayRobb Vanilla Flavored Egg White Protein Powder. Net Weight 24 oz (1.5 lbs) 680g Dietary Supplement. UPC 6 03907-00462 32023-10-13
- USDA FSISCustom Made Meals, LLC Retira Producto Envuelto En Tocino Con Jalapeño Debido A Un Error De Rotulación Y Un Alérgeno No Declarado2023-09-09
- CPSCCustom Elevator Recalls Residential Elevators Due to Child Entrapment Hazard; Risk of Serious Injury or Death to Young Children; One Death Reported2022-09-29
- FDASermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 750812022-04-05
- FDALL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA2022-04-05
- FDABPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 750812022-04-05
- FDAARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA2022-04-05
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