Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use recall — FDA D-0906-2018
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
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Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Presence of foreign substance: glass particles
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powder on natural rubber latex gloves can aerosolize latex allergens, resulting in…
The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
Product sterility may be compromised due to unsealed packaging.
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle…
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses…
Product sterility may be compromised due to unsealed packaging.
Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle…
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
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