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Due to incomplete seals in the pouch which provide the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Presence of foreign substance: identified as aluminum.
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Imported Frozen Oyster potentially contaminated with Norovirus.
Ramen Noodle package label does not declare Soy as the source for lecithin ingredient.
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
Potential for open header bag seals, compromising sterility.
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Contains undeclared wheat. The top label identifies the product as potato salad, but the unit contains pasta salad.
Lack of Assurance of Sterility.
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The failure modes have never been found to occur in these models, whether in the field or factory, but could potentially occur under excessive force or extreme, continuous vibration.
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.