Med Tec Recalls CIVCO Rigid Arm Supports for Height Discrepancy
Med Tec Inc is recalling CIVCO Rigid Arm Supports used in Posiboard-2 and Posirest assemblies due to a potential 17mm height difference.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries or illnesses, fitting the criteria for a moderate severity recall involving a potential defect without reported harm.
Plain-English summary
Med Tec Inc is recalling 30 units of CIVCO Rigid Arm Supports, Reference 106047, which were distributed as various part numbers including 106047, 109040, 106048, and 106522. These supports are utilized on Posiboard-2 and Posirest assemblies intended to position patients' upper extremities during breast and lung diagnostic and radiotherapy treatment.
The recall is issued because the Rigid Arm Supports may have a height difference of approximately 17mm. The affected units were distributed between October 2009 and July 2012. The source text does not report any illnesses, injuries, or deaths associated with this defect.
The products were distributed worldwide, including in the United States (Michigan, Illinois, and Texas) and numerous international locations. Med Tec Inc is the recalling firm. Consumers and healthcare facilities should contact the manufacturer for instructions on how to proceed with the recall.
The recalled product
- Product
- CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the…
- Manufacturer
- Med Tec Inc
- Hazard
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Codes: M181690
- M194500
- M203470
- M213330
- M216050
- M142180
- M143110
- M149600
- 0154710
- M158550
- M165330
- M16900
- M169330
- M142230
- M149650
- M236810
Distribution
Part of a larger recall action
This product is one of 2 recalled by Med Tec Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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