Z-2237-2009

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

Name: Z-2237-2009 Action Products, Inc., Bol-X-II, 30x30x1.0cm, item number 32102, packaged 10/carton. Polymer pad used during...
Creator: Action Products Incorporated
Published: 2009-06-26
License: https://open.fda.gov/license/

Action Products, Inc. / initiated 2009-06-26 / Terminated / root cause: manufacturing process

FDA source

Action Products Incorporated began a recall of Action Products, Inc., Bol-X-II, 30x30x1.0cm, item number 32102, packaged 10/carton. Polymer pad used during radiation therapy on 2009-06-26. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2237-2009
Status: Terminated
Initiated: 2009-06-26
Posted: 2009-09-22
Terminated: 2009-09-29
Recalling firm: Action Products, Inc.
Product: Action Products, Inc., Bol-X-II, 30x30x1.0cm, item number 32102, packaged 10/carton. Polymer pad used during radiation therapy.
Product code: JAD System, Therapeutic, X-Ray
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Action Products Inc. notified one affected distributor by phone and email on 06/26/09 and issued a Return Merchandise Authorization.
Quantity in commerce: 1 carton
Distribution: Nationwide distribution.
Product codes and lots: I1PIT-0000

Product code JAD

K811528Class IIRadiation BolusAction Products, Inc. / cleared 1981-07-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)