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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.
Joy Salty Lassi 16 oz.
Product not adequately pasteurized
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.
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, t...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC01...
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, b...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (...
Subpotent Drug
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.
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.
les moulinettes - coquillettes blé dur
taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire
terres de moulin madame - farine de blé dur fine et complète
taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire
Personalised bling dummy and clip set
The dummy and clip set does not comply with the mandatory standard for baby dummies and dummy chains . The decorations may detach from the dummy and clip. The dummy’s chain is too long.
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.
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro...
Potential for thrombus formation during prolonged use of the introducer.
boichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybe...
Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
5# Sunflower Seeds C/NS
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
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.
Honda (American Honda Motor Co.) - Improperly Tightened Rear Subframe Bolts
Loose rear subframe bolts can lead to a loss of vehicle stability or rear subframe detachment, increasing the risk of a crash or injury.
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).
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.
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isop...
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
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.
Joy Masala Chaash Lassi 16 oz., 64 oz.
Product not adequately pasteurized