Class 2 Device Recall MicroKill

• Date Initiated by Firm: December 29, 2021
• Date Posted: March 01, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0696-2022
• Recall Event ID: 89440
• Product Classification: Disinfectant, medical devices - Product Code LRJ
• Product: MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes
• Code Information: a. Model No.: MSC351400AN; UDI: 10888277652514; Lot No.: 209 and Batch ID: 20083 Lot No.: 210 and Batch ID: 20085 Lot No.: 211 and Batch ID: 20083 and 20084 Lot No.: 212 and Batch ID: 20084 and 20085 Lot No.: 213 and Batch ID: 20085 and 20086 Lot No.: 214 and Batch ID: 20086 and 20087 Lot No.: 215 and Batch ID: 20087 Lot No.: 216 and Batch ID: 20087 and 20090 Lot No.: 217 and Batch ID: 20090 Lot No.: 218 and Batch ID: 20090 and 20091 Lot No.: 231 and Batch ID: 20104 and 20105 Lot No.: 233 and Batch ID: 20105, 20106, and 20107 Lot No.: 235 and Batch ID: 20107 and 20108 Lot No.: 236 and Batch ID: 20108, 20109, and 20111 Lot No.: 238 and Batch ID: 20111 and 20112 Lot No.: 240 and Batch ID: 20112 and 20113 Lot No.: 241 and Batch ID: 20113 and 20114 Lot No.: 243 and Batch ID: 20114 and 20115 Lot No.: 244 and Batch ID: 20115 Lot No.: 245 and Batch ID: 20115 and 20118 Lot No.: 246 and Batch ID: 20118 Lot No.: 247 and Batch ID: 20118 and 20119 Lot No.: 248 and Batch ID: 20119 Lot No.: 249 and Batch ID: 20119 and 20120 Lot No.: 250 and Batch ID: 20120 Lot No.: 254 and Batch ID: 20132 Lot No.: 256 and Batch ID: 20132and 20133 Lot No.: 258 and Batch ID: 20136 and 20137 Lot No.: 260 and Batch ID: 20137 and 20139 Lot No.: 261 and Batch ID: 20139 and 20140 Lot No.: 263 and Batch ID: 20140 and 20141 Lot No.: 264 and Batch ID: 20141 and 20142 Lot No.: 288 and Batch ID: 20219 Lot No.: 289 and Batch ID: 20219 and 20220 Lot No.: 290 and Batch ID: 20220 and 20221 Lot No.: 291 and Batch ID: 20221 and 20223 Lot No.: 292 and Batch ID: 20223 and 20224 Lot No.: 293 and Batch ID: 20224, 20225, and 20232 Lot No.: 301 and Batch ID: 20293 and 20294 Lot No.: 302 and Batch ID: 20294 and 20295 Lot No.: 303 and Batch ID: 20295 and 20296 Lot No.: 304 and Batch ID: 20296 Lot No.: 305 and Batch ID: 20297, 20300, and 20301 Lot No.: 306 and Batch ID: 20300, 20301, and 20424 Lot No.: 307 and Batch ID: 20315 Lot No.: 308 and Batch ID: 20315 and 20316 Lot No.: 309 and Batch ID: 20316 and 20317 Lot No.: 310 and Batch ID: 20317 and 20318 Lot No.: 311 and Batch ID: 20318 Lot No.: 343 and Batch ID: 21047 and 21048 Lot No.: 344 and Batch ID: 21048 and 21049 Lot No.: 345 and Batch ID: 21049 and 21050 Lot No.: 346 and Batch ID: 21050 Lot No.: 347 and Batch ID: 21050 and 20153 Lot No.: 348 and Batch ID: 21053 and 21054 Lot No.: 352 and Batch ID: 21063 Lot No.: 353 and Batch ID: 21063 and 21064 Lot No.: 354 and Batch ID: 21064 Lot No.: 355 and Batch ID: 21064 and 21067 Lot No.: 356 and Batch ID: 21067 Lot No.: 360 and Batch ID: 21112 Lot No.: 361 and Batch ID: 21102 and 21103 Lot No.: 362 and Batch ID: 21103, 21105, 21109, and 21173 Lot No.: 363 and Batch ID: 21109 and 21110 Lot No.: 364 and Batch ID: 21110 and 21111 Lot No.: 365 and Batch ID: 21111 and 21112 Lot No.: 366 and Batch ID: 21112 Lot No.: 367 and Batch ID: 21116 and 21173 Lot No.: 368 and Batch ID: 21116 and 21117 Lot No.: 369 and Batch ID: 21117 Lot No.: 370 and Batch ID: 21117 and 21118 b. Model No.: MSC351410AN; UDI: 10888277652521; Lot No.: 208 and Batch ID: 20079 Lot No.: 209 and Batch ID: 20080, 20083, and 20303 Lot No.: 210 and Batch ID: 20083, 20084, 20085, and 20086 Lot No.: 213 and Batch ID: 20086 Lot No.: 214 and Batch ID: 20086 and 20087 Lot No.: 215 and Batch ID: 20087 Lot No.: 216 and Batch ID: 20087 and 20090 Lot No.: 217 and Batch ID: 20090 Lot No.: 218 and Batch ID: 20090 and 20091 Lot No.: 219 and Batch ID: 20091 and 20092 Lot No.: 220 and Batch ID: 20092, 20093, and 20094 Lot No.: 222 and Batch ID: 20094 and 20095 Lot No.: 224 and Batch ID: 20095, 20097, and 20098 Lot No.: 226 and Batch ID: 20098 and 20099 Lot No.: 228 and Batch ID: 20099, 20100, and 20101 Lot No.: 229 and Batch ID: 20104 Lot No.: 230 and Batch ID: 20101, 20104, and 20105 Lot No.: 232 and Batch ID: 20105 and 20106 Lot No.: 234 and Batch ID: 20106, 20107, and 20108 Lot No.: 237 and Batch ID: 20108 and 20109 Lot No.: 239 and Batch ID: 20113 Lot No.: 242 and Batch ID: 20113 and 20114 Lot No.: 252 and Batch ID: 20125 Lot No.: 253 and Batch ID: 20125 and 20126 Lot No.: 267 and Batch ID: 20153 Lot No.: 268 and Batch ID: 20153 and 20154 Lot No.: 269 and Batch ID: 20154 and 20155 Lot No.: 270 and Batch ID: 20155 and 20156 Lot No.: 271 and Batch ID: 20156 and 20157 Lot No.: 277 and Batch ID: 20167 and 20168 Lot No.: 279 and Batch ID: 20168 and 20169 Lot No.: 280 and Batch ID: 20169 and 20170 Lot No.: 282 and Batch ID: 20170 and 20171 Lot No.: 293 and Batch ID: 20232 Lot No.: 294 and Batch ID: 20232 and 20233 Lot No.: 295 and Batch ID: 20266 Lot No.: 296 and Batch ID: 20266, 20615, and 20616 Lot No.: 297 and Batch ID: 20266, 20267, and 20616 Lot No.: 298 and Batch ID: 20267 Lot No.: 299 and Batch ID: 20268, 20269, and 20620 Lot No.: 300 and Batch ID: 20290 and 20293 Lot No.: 307 and Batch ID: 20314 and 20315 Lot No.: 311 and Batch ID: 20322 Lot No.: 312 and Batch ID: 20322 and 20323 Lot No.: 321 and Batch ID: 20346 and 20347 Lot No.: 322 and Batch ID: 20347, 20348, and 20349 Lot No.: 323 and Batch ID: 20349 and 20350 Lot No.: 328 and Batch ID: 20353 Lot No.: 336 and Batch ID: 21008 and 21009 Lot No.: 338 and Batch ID: 21009, 21010, and 21011 Lot No.: 340 and Batch ID: 21011, 21012, and 21013 Lot No.: 341 and Batch ID: 21013 and 21014 Lot No.: 342 and Batch ID: 21014 and 21047 Lot No.: 356 and Batch ID: 21068 Lot No.: 357 and Batch ID: 21068 and 21069 Lot No.: 358 and Batch ID: 21069 and 21070 Lot No.: 359 and Batch ID: 21075 and 21076 Lot No.: 360 and Batch ID: 21076 c. Model No.: MSC351440AN; UDI: 10888277652538; Lot No.: 208 and Batch ID: 20078, 20221 and 20275
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 866-359-1704
• Manufacturer Reason for Recall: Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm initiated the recall on January 13, 2022 and provided each consignee with a letter and a response form to record their response to the recall notification. Each response received will be recorded and the firm will send subsequent letters to consignees that have not provided a response to the recall notification in the allotted time. The letter explained the issue and requested return of the product, if available. Customers will be responsible for initiating sub-recall procedures. Any recalled product that is returned from customers will be quarantined at the firm's corporate office pending destruction. The firm expanded the original recall notification dated January 13, 2022 to include additional lots of the Micro-Kill Bleach Germicidal Bleach Wipes due to product not meeting label claim for Sodium Hypochlorite content. A letter was sent out to all consignees within the scope of the expanded recall on 02/25/2022 with the same instructions. The firm sent a letter dated July 27, 2022, to previous non-responding consignees instructing them to destroy any affected product per their local and state regulations and document the destruction.
• Quantity in Commerce: 359,524 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Panama and Bermuda.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.