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 Counters.
All Recalls
95,075 total recalls in our database
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.
10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501
Arrow International
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 incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.
Product sterility may be compromised due to unsealed packaging.
Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
Arrow International
Product sterility may be compromised due to unsealed packaging.
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 Counters.
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW
Arrow International
Product sterility may be compromised due to unsealed packaging.
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
Draeger Medical
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.
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
WRP Asia Pacific Sdn Bhd
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 sensitization to latex and allergic reactions. Additional risks of powdered gloves include severe airway inflammation, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue.
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.
Maximal Barrier Drape; Product Code: ASK-01000-UPMS
Arrow International
Product sterility may be compromised due to unsealed packaging.
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
Arrow International
Product sterility may be compromised due to unsealed packaging.
Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018
Arrow International
Product sterility may be compromised due to unsealed packaging.
Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
Arrow International
Product sterility may be compromised due to unsealed packaging.
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC
Arrow International
Product sterility may be compromised due to unsealed packaging.
Cool White Universal T8/T12 LED tube lamps
Unknown Manufacturer
The pins on one end of the lamp can be energized during installation/removal, posing electric shock and electrocution hazards.
Vernier Circuit Board 2
Charles Assembly, of Aloha, Ore.
There are two switches on the VCB2 that can get stuck between positions causing the switches to short out and overheat. If the switches overheat, the metal case of the switch can become hot, posing a burn hazard.