Recall Z-0520-2013
Advanced Sterilization Products · initiated October 3, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.
Codes / lots: Lot: 225117 337117 295117 334117 227117 338117 296117 326117 227118 264117 300117 327117 230117 265117 301117 330117 233117 266117 302117 331117 235117 267117 310117 331118 235118 268117 311117 332117 237117 269117 312117 335117 239117 270117 313117 341111 241117 273117 314117 343111 242117 275117 315117 348111 243117 277117 316117 350111 244117 278117 317117 245117 280117 318117 246117 281117 319117 249117 282117 321111 253117 283117 321117 255117 284117 322111 257117 285117 322117 259117 287117 323111 261117 289117 323117 263117 291117 324117 333117 292117 325111 334111 294117 325117 336111 357111 333111 04581Z 07781Z 10081Z 14881Z 04681Z 07482Z 10082Z 14981Z 04781Z 07981Z 10381Z 15081Z 04981Z 07881Z 10981Z 15281Z 05081Z 07581Z 10881A 15681Z 05281Z 08181Z 10581Z 15781Z 05181Z 07381Z 10681A 15881Z 05681Z 08481Z 10181Z 15981A 05781Z 08081Z 10281Z 15481Z 05981Z 08281Z 10282A 16381Z 05782Z 08482Z 11281Z 16481Z 06081Z 08581Z 10882Z 16881Z 06181Z 08582Z 11381Z 16181A 06182Z 08681Z 11081A 16581Z 05381Z 08682Z 11082Z 16981Z 05881Z 08781Z 11481Z 17081Z 05982Z 08881A 11681Z 17281A 06381Z 08981Z 12081Z 17581Z 06481Z 07782Z 12181Z 17781A 06482Z 09181Z 12381Z 17981A 06581Z 09281Z 12881Z…
Reason for recall
Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December 2011 because it may not have adequate data to support the entire duration of the labeled shelf-life.
FDA-determined cause: Nonconforming Material/Component
Action taken
Advanced Sterilization Products (ASP) sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) letter dated November 2, 2012 to all customers who received the Sterrad Cyclesure 24 Biological Indicator (BI) product P/N 14324 manufactured between February 2008 and December 2011. The letter informed the customers of the problem identified and the actions to be taken. ASP determined that the 24 BI may not have adequate data to support the entire duration of the labeled shelf life of affected product manufactured during the above timeframe. The letter also informed customers that this is a different recall from the previous July 3, 2012 STERRAD CYCLESURE 24 BI recall. Customers with questions or need additional packing labels are instructed to call Stericycle at (877) 650-7692.
Details
- Recall number
- Z-0520-2013
- Initiated
- October 3, 2012
- Posted by FDA
- December 12, 2012
- Terminated
- July 19, 2013
- Product code
- FRC – Indicator, Biological Sterilization Process
- Quantity
- 38,532 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of AR, AU, BE, BR, CA, CL, CN, CO, EC, GT, HK, ID, IN, JP, KR, MX, MY, PA, PE, PH, SG, TH, VE, and RU.
- Recalling firm
- Advanced Sterilization Products, Irvine, CA