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MID CENTRAL MEDICAL CORP. · Model MCM107 · UDI-DI 10810030860249

FWZ
10
510(k) clearances
1,818
Adverse events (2 deaths)
37
Recalls
159
Facilities

Description

Anesthesia Protection Shield. This stainless steel anesthesia shield is designed to protect the patient’s face during surgery and also provides a frame for the anesthesia drape. Constructed of durable stainless steel, it attaches to the OR table rail with two stainless steel side rail sockets (MCM-162 sold separately). Top surface measures 18 1/4" by 22 1/4" and the side supports are 24"L to adjust to the desired height. Side supports measure 1/8" x 1". The flat tray portion can be used to support instruments during surgery. Allows full patient access for anesthesia monitoring. Fully welded stainless steel construction makes it easy to clean and durable.

Recalls

DateFirmReason
2024-02-14Baxter Healthcare CorporationThree lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the
2017-03-28Mizuho OSIMizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to contact the underlying
2015-08-17Maquet Cardiovascular Us Sales, LlcTwo serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) fo
2015-08-17Maquet Cardiovascular Us Sales, LlcTwo serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) fo
2014-12-19Integra LifeSciences CorporationThrough an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.
2014-10-08Customed, IncSignificant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage condit
2014-10-08Customed, IncCustomed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncont
2014-10-08Customed, IncSignificant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage condit
2014-10-08Customed, IncSignificant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage condit
2014-10-08Customed, IncCustomed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncont

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.