FDADecember 11, 2014device
Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
What to do
FDA enforcement status: Terminated
Brands named
med tecmed
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAhuman med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.2024-10-18
- FDABrand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID2024-08-26
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- FDABrand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID2024-08-26
- FDAMi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant2024-04-18
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