Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., I

FDA device recall Z-2330-2008 · posted 2008-09-20 · Terminated

Recall details

Recalling firm

Propper Mfg Co Inc

Reason for recall

The firm discovered a production specification discrepancy that may cause the indicators to show an inaccurate result.

Action taken

On 2/07/08, Propper Mfg. Co. sent URGENT: DEVICE RECALL letters (dated 2/07/08) to the direct consignees, informing them of the recall of the affected lots of Gas-Chex EO Indicator Strips. The letters also instructed them to: (1) check their inventory to determine if they have the recalled lots in stock; (2) discontinue use of the affected lots; (3) reprocess any unused packs that have been processed with the affected lots of Gas-Chex EO Indicator Strips with non-recalled lots or an alternative product from another supplier; (4) return the affected lots to Propper Manufacturing; (5) complete the enclosed form and return via fax to Propper Mfg. Propper Mfg. will send a postage-paid label and instruction for return of the product, and will ship replacement product as soon as possible. Propper also recommended that consignees review the risk associated with items that have been monitored with the subject chemical indicators although a sterilization cycle failure is unlikely due to equipment controls and other monitoring methods. For questions, please contact Propper at 1-800-832-4300 during regular business hours (9 am to 4:30 pm).

Root cause

Equipment maintenance

Status

Terminated

Product code

JOJ

Quantity affected

1757 cases (7030 boxes)

Distribution

Nationwide and Puerto Rico

Date initiated

2008-02-07

Date posted

2008-09-20

Date terminated

2012-08-03

Location

City, NY