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Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Num...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
les moulinettes - fusilli semi-complète
taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
carrefour bio - abricots moelleux carrefour bio 250 g dénoyautés
présence de sulfites, non mentionnée sur l’étiquetage
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
les moulinettes - penne blé dur
taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire
5# Sunflower Seeds C/S
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide ...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Eunha Fisheries Co., LTD. Issues Allergy Alert on Undeclared Wheat, Soy, and Sesame in Certain Frozen Olive Flounder Sashimi Products
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, ...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the follo...
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60...
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
1) Spring & Mulberry Pure Dark Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), ...
Potential Salmonella contamination
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical I...
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: ...
CGMP Deviations
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, M...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Octopus Evolution AS Tissue Stabilizer, Model TS2500
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ ...
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL He...
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx on...
Presence of foreign substance
BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v iso...
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs,...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Joy Mango Lassi 16 oz., 64 oz.
Product not adequately pasteurized