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Terminated

Action Products, Inc., Bol-X-II, 30x30x1.0cm, item number 32102, packaged 10/carton. Polymer pad used during radiation therapy.

FDA Recall Z-2237-2009 · Posted 2009-09-22

Recalling FirmAction Products Incorporated
Recall StatusTerminated
Product CodeJAD
Date Initiated2009-06-26
Date Terminated2009-09-29
Product Quantity1 carton

Reason for Recall

Medical device intended for use by healthcare practitioners was incorrectly labeled. 1.0 cm thick pad was labeled as 0.5 cm thickness, and vice versa.

Firm Action

Action Products Inc. notified one affected distributor by phone and email on 06/26/09 and issued a Return Merchandise Authorization.

Root Cause

Process control

Distribution Pattern

Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K811528RADIATION BOLUSAction Products, Inc. · 1981-07-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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