The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Wright Medical Technology
Class I - Dangerous
Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.
Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Class I - Dangerous
Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Attachment of the localizer is typically accomplished by fully screwing in the four thumbscrews of the localizer into the threaded holes found on the top surface of the Skull Anchor Key.
Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Class I - Dangerous
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Class I - Dangerous
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Class I - Dangerous
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Class I - Dangerous
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Class I - Dangerous
Update to contraindications and warning language due to CPAP masks containing magnets.
Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Phantom 2 Nasal Vented Mask
SleepNet
Class I - Dangerous
Update to contraindications and warning language due to CPAP masks containing magnets.
Class I - Dangerous
Update to contraindications and warning language due to CPAP masks containing magnets.
MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Class I - Dangerous
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Class I - Dangerous
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Ureteral dilator, REF RBD014
Coloplast Manufacturing US
Class I - Dangerous
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Class I - Dangerous
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Class I - Dangerous
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).