A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Gambro Renal Products, Incorporated
Class I - Dangerous
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
Class I - Dangerous
The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
Class I - Dangerous
A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
Class I - Dangerous
The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
Class I - Dangerous
The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Gambro Renal Products, Incorporated
Class I - Dangerous
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
Class I - Dangerous
The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
JK Bariatric Beds, True Air Technologies, Inc.
SCM True Air Technologies
Class I - Dangerous
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
SCM True Air Technologies
Class I - Dangerous
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
Siemens Medical Solutions USA
Class I - Dangerous
There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
SCM True Air Technologies
Class I - Dangerous
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
Fresenius Medical Care Holdings
Class I - Dangerous
Naturalyte Liquid Bicarbonate maybe contaminated
Class I - Dangerous
During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
The Anspach Effort
Class I - Dangerous
Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.
The donor was hemodiluted.
Class I - Dangerous
All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on th
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Siemens Healthcare Diagnostics
Class I - Dangerous
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.