Reported Sep 6, 2017 · Terminated
CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm…
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 106015
- distributed as(a) Rigid Arm Support, Standard
- Set Red (PN106015) (b) Rigid Adj. Arm Support
- Set (PN106020) (c)
- PSR2-CR-DLR-2P Posirest-2 (PN106521) (d)
- PB2-BLR Posiboard-2 (PN109030) 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
M207190M212200M141830M142280M144220M149540M149550M149560M149580M164440M164470M177290M177330M177340M198070M198100M285840M133130M137690M138630M138640M138650M165550M165560M180420M180430M180440M189150M217660M217670M217680M217710
- Codes
- Amount recalled
- 101 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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