Class I - Dangerous
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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Infusion Pumps
🏥 Medical Devices • 4,262 recalls
When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.
Class I - Dangerous
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Class I - Dangerous
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Class I - Dangerous
Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 TxT Treatment Table. Combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the TxT" Treatment Table has been damaged due to contacting a moving part. The resulting short-circuit cau
Class I - Dangerous
Sterility of device may be compromised due to lack of pouch seal integrity
Class I - Dangerous
BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely impacts unit package integrity and product sterility.
Class I - Dangerous
Sterility of device may be compromised due to lack of pouch seal integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of pouch seal integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of pouch seal integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of pouch seal integrity
Class I - Dangerous
Product did not reach expected sterility assurance level
Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.
Class I - Dangerous
Sterility of device may be compromised due to lack of pouch seal integrity
Class I - Dangerous
The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.
***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone.
The Anspach Effort
Class I - Dangerous
The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..
Class I - Dangerous
Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
Class I - Dangerous
Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.
Class I - Dangerous
Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.