3M Comply EO Chemical Indicators Strips, Catalog #1251 The Comply 1251 Chemical Indicator Strip is a paper strip 1.5cm w

FDA device recall Z-1568-2008 · posted 2008-08-08 · Terminated

Recall details

Recalling firm

3M Company / Medical Division

Reason for recall

A production specification discrepancy may cause the indicators to show an inaccurate result, which could incorrectly lead customers to conclude the sterilization cycle was adequate.

Action taken

Customers and Distributors were each sent a "Voluntary Product Recall" letter dated 3/17/08 on 3/19/08. The letter states that use of the affected product should immediately be discontinued, stocks should be checked for any remaining inventory, and reprocess any unused packs using the product not from the affected lot or from an alternative supplier. The letter requested consignees to notify 3M whether the facility has affected product or not by sending the "Product Return Form". Replacements will be provided to those with affected products remaining in their stock.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JOJ

Quantity affected

12,998 cases ( 4 boxes per case & 480 strips per box))

Distribution

Nationwide Distribution --- including states of AL, AR, AZ, CA, CO, CT,DC, DE, FL, GA,HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS,MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC,

Date initiated

2008-03-19

Date posted

2008-08-08

Date terminated

2012-03-01

Location

South St Paul, MN