Reported Sep 6, 2017 · Terminated
CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN:…
Med Tec Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Med Tec Inc · PO Box 320 · Orange City, IA · 51041-7463
Is this the product you have?
- CIVCO Arm Support, REF 106047
- distributed as(a) Rigid Arm Support, Large, Set
- Red (PN106047) (b)
- PB2-BDLRL (PN109040) (c) Rigid Adj. Arm Support, Large
- Set (PN106048) (d)
- PSR2-CF-DLRL-2P Posirest-2 (PN106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment
- Lot codes and dates
- Codes
M181690M194500M203470M213330M216050M142180M143110M1496000154710M158550M165330M16900M169330M142230M149650M236810
- Codes
- Amount recalled
- 30 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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