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U.S. Department of Health and Human Services

Class 2 Device Recall Blake Silicone Drain

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  Class 2 Device Recall Blake Silicone Drain see related information
Date Initiated by Firm March 24, 2011
Date Posted July 07, 2011
Recall Status1 Terminated 3 on January 10, 2014
Recall Number Z-2756-2011
Recall Event ID 58335
510(K)Number k953655  
Product Classification Endoscope and/or accessories - Product Code KOG
Product Blake Silicone Drain, 1 unit, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151.

Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potentially detrimental collection of certain fluids (e.g. pus, extravascular blood, bile) from wounds in body cavities and to reduce the risk of infection.
Code Information BLAKE¿SiliconeDrain 2210 J100011 Mar2015 BLAKE¿SiliconeDrain 2210 J100174 Apr2015 BLAKE¿SiliconeDrain 2210 J101607 May2015 BLAKE¿SiliconeDrain 2210 J108130 Jul2015 BLAKE¿SiliconeDrain 2211 J100663 Apr2015 BLAKE¿SiliconeDrain 2211 J100664 Apr2015 BLAKE¿SiliconeDrain 2211 J100665 Apr2015 BLAKE¿SiliconeDrain 2211 W00025525 Mar2015 BLAKE¿SiliconeDrain 2212 J100371 Apr2015 BLAKE¿SiliconeDrain 2212 J100675 Apr2015 BLAKE¿SiliconeDrain 2212 J101270 Apr2015 BLAKE¿SiliconeDrain 2212 J103980 Jun2015 BLAKE¿SiliconeDrain 2212 W00021390 Feb2015 BLAKE¿SiliconeDrain 2213 J100140 Mar2015 BLAKE¿SiliconeDrain 2213 J101503 May2015 BLAKE¿SiliconeDrain 2213 J102391 May2015 BLAKE¿SiliconeDrain 2213 W00025507 Mar2015 BLAKE¿SiliconeDrain 2214 J100079 Mar2015 BLAKE¿SiliconeDrain 2214 J100080 Mar2015 BLAKE¿SiliconeDrain 2214 J100672 Apr2015 BLAKE¿SiliconeDrain 2214 J1011952 Aug2015 BLAKE¿SiliconeDrain 2214 J101527 May2015 BLAKE¿SiliconeDrain 2214 J1015775 Sep2015 BLAKE¿SiliconeDrain 2214 J102897 May2015 BLAKE¿SiliconeDrain 2214 J103976 Jun2015 BLAKE¿SiliconeDrain 2214 W00025526 Mar2015 BLAKE¿SiliconeDrain 2215 J100195 Mar2015 2379_01_02AS Page 2 of 9 Product Name Product Code Lot # Product Expiration Date BLAKE¿SiliconeDrain 2215 J101275 Apr2015 BLAKE¿SiliconeDrain 2215 J103988 Jun2015 BLAKE¿SiliconeDrain 2215 J105466 Jul2015 BLAKE¿SiliconeDrain 2215 J108248 Jul2015 BLAKE¿SiliconeDrain 2215 W00021391 Feb2015 BLAKE¿SiliconeDrain 2215 W00024326 Feb2015 BLAKE¿SiliconeDrain 2216 J100010 Mar2015 BLAKE¿SiliconeDrain 2216 J101249 Apr2015 BLAKE¿SiliconeDrain 2216 J101511 May2015 BLAKE¿SiliconeDrain 2217 J100183 Apr2015 BLAKE¿SiliconeDrain 2217 J101518 May2015 BLAKE¿SiliconeDrain 2217 J103422 Jun2015 BLAKE¿SiliconeDrain 2217 J104968 Jun2015 BLAKE¿SiliconeDrain 2217 J105443 Jul2015 BLAKE¿SiliconeDrain 2217 J108182 Jul2015 BLAKE¿SiliconeDrain 2217 J108183 Jul2015 BLAKE¿SiliconeDrain 2217 W00024310 Feb2015 BLAKE¿SiliconeDrain 2226 J100249 Apr2015 BLAKE¿SiliconeDrain 2226 J100250 Apr2015 BLAKE¿SiliconeDrain 2226 J101078 Apr2015 BLAKE¿SiliconeDrain 2226 J101356 May2015 BLAKE¿SiliconeDrain 2226 J104133 Jun2015 BLAKE¿SiliconeDrain 2226 J104134 Jun2015 BLAKE¿SiliconeDrain 2226 J108547 Jul2015 BLAKE¿SiliconeDrain 2226 W00020317 Jan2015 BLAKE¿SiliconeDrain 2226 W00023327 Feb2015 BLAKE¿SiliconeDrain 2226 W00024413 Mar2015 BLAKE¿SiliconeDrain 2227 J100001 Mar2015 BLAKE¿SiliconeDrain 2227 J100282 Mar2015 BLAKE¿SiliconeDrain 2227 J1010653 Aug2015 BLAKE¿SiliconeDrain 2227 J101149 Apr2015 BLAKE¿SiliconeDrain 2227 J102696 Jun2015 BLAKE¿SiliconeDrain 2227 J103190 Jun2015 BLAKE¿SiliconeDrain 2227 J103191 Jun2015 BLAKE¿SiliconeDrain 2227 J105240 Jun2015 BLAKE¿SiliconeDrain 2227 J107777 Jul2015 BLAKE¿SiliconeDrain 2227 J107778 Jul2015 BLAKE¿SiliconeDrain 2227 J107779 Aug2015 BLAKE¿SiliconeDrain 2227 J108755 Aug2015 BLAKE¿SiliconeDrain 2227 J108758 Aug2015 BLAKE¿SiliconeDrain 2227 J109711 Aug2015 BLAKE¿SiliconeDrain 2227 W00020300 Feb2015 2379_01_03AS Page 3 of 9 Product Name Product Code Lot # Product Expiration Date BLAKE¿SiliconeDrain 2227 W00020316 Jan2015 BLAKE¿SiliconeDrain 2227 W00023338 Feb2015 BLAKE¿SiliconeDrain 2227 W00023355 Feb2015 BLAKE¿SiliconeDrain 2227 W00023390 Feb2015 BLAKE¿SiliconeDrain 2227 W00023393 Feb2015 BLAKE¿SiliconeDrain 2227 W00024340 Apr2015 BLAKE¿SiliconeDrain 2227 W00025488 Mar2015 BLAKE¿SiliconeDrain 2227 W00025544 Mar2015 BLAKE¿SiliconeDrain 2227 W00026535 Feb2015 BLAKE¿SiliconeDrain 2227 W00026536 Feb2015 BLAKE¿SiliconeDrain 2228 J1010447 Aug2015 BLAKE¿SiliconeDrain 2228 J101360 May2015 BLAKE¿SiliconeDrain 2228 J101361 May2015 BLAKE¿SiliconeDrain 2228 J101617 May2015 BLAKE¿SiliconeDrain 2228 J104141 Jun2015 BLAKE¿SiliconeDrain 2228 J104143 Jun2015 BLAKE¿SiliconeDrain 2228 J104145 Jun2015 BLAKE¿SiliconeDrain 2228 J104146 Jun2015 BLAKE¿SiliconeDrain 2228 J104648 Jun2015 BLAKE¿SiliconeDrain 2228 J106578 Jul2015 BLAKE¿SiliconeDrain 2228 J108566 Jul2015 BLAKE¿SiliconeDrain 2229 J101176 Apr2015 BLAKE¿SiliconeDrain 2229 J101177 Apr2015 BLAKE¿SiliconeDrain 2229 J101178 Apr2015 BLAKE¿SiliconeDrain 2229 J101179 May2015 BLAKE¿SiliconeDrain 2229 J102268 May2015 BLAKE¿SiliconeDrain 2229 J103789 Jun2015 BLAKE¿SiliconeDrain 2229 J105288 Jul2015 BLAKE¿SiliconeDrain 2229 J105289 Jul2015 BLAKE¿SiliconeDrain 2229 J105290 Jul2015 BLAKE¿SiliconeDrain 2229 J105291 Jul2015 BLAKE¿SiliconeDrain 2229 J105296 Jul2015 BLAKE¿SiliconeDrain 2229 J106885 Jul2015 BLAKE¿SiliconeDrain 2229 J107883 Jul2015 BLAKE¿SiliconeDrain 2229 J107885 Jul2015 BLAKE¿SiliconeDrain 2230 J100023 Mar2015 BLAKE¿SiliconeDrain 2230 J100024 Mar2015 BLAKE¿SiliconeDrain 2230 J100262 Apr2015 BLAKE¿SiliconeDrain 2230 J100263 Apr2015 BLAKE¿SiliconeDrain 2230 J100482 Apr2015 BLAKE¿SiliconeDrain 2230 J100484 Apr2015 BLAKE¿SiliconeDrain 2230 J100485 Apr2015 2379_01_04AS Page 4 of 9 Product Name Product Code Lot # Product Expiration Date BLAKE¿SiliconeDrain 2230 J100796 Apr2015 BLAKE¿SiliconeDrain 2230 J100797 Apr2015 BLAKE¿SiliconeDrain 2230 J100798 Apr2015 BLAKE¿SiliconeDrain 2230 J1010450 Aug2015 BLAKE¿SiliconeDrain 2230 J1010451 Aug2015 BLAKE¿SiliconeDrain 2230 J1010503 Aug2015 BLAKE¿SiliconeDrain 2230 J1010504 Aug2015 BLAKE¿SiliconeDrain 2230 J1010505 Aug2015 BLAKE¿SiliconeDrain 2230 J101097 Apr2015 BLAKE¿SiliconeDrain 2230 J101098 Apr2015 BLAKE¿SiliconeDrain 2230 J101099 Apr2015 BLAKE¿SiliconeDrain 2230 J101100 Apr2015 BLAKE¿SiliconeDrain 2230 J101101 Apr2015 BLAKE¿SiliconeDrain 2230 J1011423 Aug2015 BLAKE¿SiliconeDrain 2230 J1011424 Aug2015 BLAKE¿SiliconeDrain 2230 J1011425 Aug2015 BLAKE¿SiliconeDrain 2230 J1012315 Aug2015 BLAKE¿SiliconeDrain 2230 J1013177 Sep2015 BLAKE¿SiliconeDrain 2230 J1013178 Sep2015 BLAKE¿SiliconeDrain 2230 J1013179 Sep2015 BLAKE¿SiliconeDrain 2230 J1013180 Sep2015 BLAKE¿SiliconeDrain 2230 J101375 May2015 BLAKE¿SiliconeDrain 2230 J1013911 Sep2015 BLAKE¿SiliconeDrain 2230 J1013912 Sep2015 BLAKE¿SiliconeDrain 2230 J101467 May2015 BLAKE¿SiliconeDrain 2230 J101641 May2015 BLAKE¿SiliconeDrain 2230 J102140 May2015 BLAKE¿SiliconeDrain 2230 J103095 Jun2015 BLAKE¿SiliconeDrain 2230 J103096 Jun2015 BLAKE¿SiliconeDrain 2230 J103651 Jun2015 BLAKE¿SiliconeDrain 2230 J103652 Jun2015 BLAKE¿SiliconeDrain 2230 J104669 Jun2015 BLAKE¿SiliconeDrain 2230 J104670 Jun2015 BLAKE¿SiliconeDrain 2230 J104671 Jun2015 BLAKE¿SiliconeDrain 2230 J104673 Jun2015 BLAKE¿SiliconeDrain 2230 J104674 Jun2015 BLAKE¿SiliconeDrain 2230 J104675 Jun2015 BLAKE¿SiliconeDrain 2230 J105160 Jul2015 BLAKE¿SiliconeDrain 2230 J105161 Jul2015 BLAKE¿SiliconeDrain 2230 J105661 Jul2015 BLAKE¿SiliconeDrain 2230 J105663 Jul2015 BLAKE¿SiliconeDrain 2230 J105665 Jul2015 2379_01_05AS Page 5 of 9 Product Name Product Code Lot # Product Expiration Date BLAKE¿SiliconeDrain 2230 J105666 Jul2015 BLAKE¿SiliconeDrain 2230 J105667 Jul2015 BLAKE¿SiliconeDrain 2230 J105669 Jul2015 BLAKE¿SiliconeDrain 2230 J108603 Jul2015 BLAKE¿SiliconeDrain 2230 J109561 Jul2015 BLAKE¿SiliconeDrain 2230 W00024412 Mar2015 BLAKE¿SiliconeDrain 2230 W00025520 Mar2015 BLAKE¿SiliconeDrain 2230 W00025557 Mar2015 BLAKE¿SiliconeDrain 2231 J100005 Mar2015 BLAKE¿SiliconeDrain 2231 J100013 Mar2015 BLAKE¿SiliconeDrain 2231 J100243 Mar2015 BLAKE¿SiliconeDrain 2231 J100301 Mar2015 BLAKE¿SiliconeDrain 2231 J100302 Apr2015 BLAKE¿SiliconeDrain 2231 J100303 Apr2015 BLAKE¿SiliconeDrain 2231 J100304 Apr2015 BLAKE¿SiliconeDrain 2231 J100589 Apr2015 BLAKE¿SiliconeDrain 2231 J100590 Apr2015 BLAKE¿SiliconeDrain 2231 J100591 Apr2015 BLAKE¿SiliconeDrain 2231 J100592 Apr2015 BLAKE¿SiliconeDrain 2231 J1010822 Aug2015 BLAKE¿SiliconeDrain 2231 J101818 May2015 BLAKE¿SiliconeDrain 2231 J101819 May2015 BLAKE¿SiliconeDrain 2231 J101820 May2015 BLAKE¿SiliconeDrain 2231 J101822 May2015 BLAKE¿SiliconeDrain 2231 J104350 Jun2015 BLAKE¿SiliconeDrain 2231 J105330 Jul2015 BLAKE¿SiliconeDrain 2231 J105999 Jul2015 BLAKE¿SiliconeDrain 2231 J106000 Jul2015 BLAKE¿SiliconeDrain 2231 J106001 Jul2015 BLAKE¿SiliconeDrain 2231 J106003 Jul2015 BLAKE¿SiliconeDrain 2231 J106972 Jul2015 BLAKE¿SiliconeDrain 2231 J106974 Jul2015 BLAKE¿SiliconeDrain 2231 J106975 Jul2015 BLAKE¿SiliconeDrain 2231 J108934 Jul2015 BLAKE¿SiliconeDrain 2231 J109882 Aug2015 BLAKE¿SiliconeDrain 2231 W00021379 Feb2015 BLAKE¿SiliconeDrain 2231 W00022364 Feb2015 BLAKE¿SiliconeDrain 2231 W00024341 Mar2015 BLAKE¿SiliconeDrain 2231 W00024388 Mar2015 BLAKE¿SiliconeDrain 2231 W00024389 Mar2015 BLAKE¿SiliconeDrain 2232 J100004 Mar2015 BLAKE¿SiliconeDrain 2232 J100170 Mar2015 2379_01_06AS Page 6 of 9 Product Name Product Code Lot # Product Expiration Date BLAKE¿SiliconeDrain 2232 J100241 Mar2015 BLAKE¿SiliconeDrain 2232 J100242 Mar2015 BLAKE¿SiliconeDrain 2232 J100320 Apr2015 BLAKE¿SiliconeDrain 2232 J100322 Apr2015 BLAKE¿SiliconeDrain 2232 J100323 Apr2015 BLAKE¿SiliconeDrain 2232 J100614 Apr2015 BLAKE¿SiliconeDrain 2232 J101484 May2015 BLAKE¿SiliconeDrain 2232 J101485 May2015 BLAKE¿SiliconeDrain 2232 J101859 May2015 BLAKE¿SiliconeDrain 2232 J103346 Jun2015 BLAKE¿SiliconeDrain 2232 J104899 Jun2015 BLAKE¿SiliconeDrain 2232 J105379 Jul2015 BLAKE¿SiliconeDrain 2232 J105380 Jul2015 BLAKE¿SiliconeDrain 2232 J107059 Jul2015 BLAKE¿SiliconeDrain 2232 J109020 Jul2015 BLAKE¿SiliconeDrain 2232 W00022377 Feb2015 BLAKE¿SiliconeDrain 2232 W00022403 Feb2015 BLAKE¿SiliconeDrain 2232 W00024352 Feb2015 BLAKE¿SiliconeDrain 2232 W00024353 Feb2015 BLAKE¿SiliconeDrain 2232 W00025487 Mar2015 BLAKE¿SiliconeDrain 2232 W00026537 Mar2015 BLAKE¿SiliconeDrain 2233 J101209 Apr2015 BLAKE¿SiliconeDrain 2233 J101210 Apr2015 BLAKE¿SiliconeDrain 2234 J100155 Apr2015 BLAKE¿SiliconeDrain 2234 J100822 Apr2015 BLAKE¿SiliconeDrain 2234 J101121 Apr2015 BLAKE¿SiliconeDrain 2234 J101122 Apr2015 BLAKE¿SiliconeDrain 2234 J101123 Apr2015 BLAKE¿SiliconeDrain 2234 J101125 Apr2015 BLAKE¿SiliconeDrain 2234 J1011505 Aug2015 BLAKE¿SiliconeDrain 2234 J1013254 Aug2015 BLAKE¿SiliconeDrain 2234 J101397 May2015 BLAKE¿SiliconeDrain 2234 J101398 May2015 BLAKE¿SiliconeDrain 2234 J1013983 Sep2015 BLAKE¿SiliconeDrain 2234 J1013984 Sep2015 BLAKE¿SiliconeDrain 2234 J101399 May2015 BLAKE¿SiliconeDrain 2234 J1015421 Sep2015 BLAKE¿SiliconeDrain 2234 J101685 May2015 BLAKE¿SiliconeDrain 2234 J103147 May2015 BLAKE¿SiliconeDrain 2234 J103700 Jun2015 BLAKE¿SiliconeDrain 2234 J104215 Jun2015 BLAKE¿SiliconeDrain 2234 J104217 Jun2015 2379_01_07AS Page 7 of 9 Product Name Product Code Lot # Product Expiration Date BLAKE¿SiliconeDrain 2234 J104218 Jun2015 BLAKE¿SiliconeDrain 2234 J104219 Jun2015 BLAKE¿SiliconeDrain 2234 J105203 Jul2015 BLAKE¿SiliconeDrain 2234 J105204 Jul2015 BLAKE¿SiliconeDrain 2234 J105754 Jul2015 BLAKE¿SiliconeDrain 2234 J105755 Jul2015 BLAKE¿SiliconeDrain 2234 J105756 Jul2015 BLAKE¿SiliconeDrain 2234 J105757 Jul2015 BLAKE¿SiliconeDrain 2234 J105758 Jul2015 BLAKE¿SiliconeDrain 2234 J106711 Jul2015 BLAKE¿SiliconeDrain 2234 J106712 Jul2015 BLAKE¿SiliconeDrain 2234 J106714 Jul2015 BLAKE¿SiliconeDrain 2234 J106715 Jul2015 BLAKE¿SiliconeDrain 2234 J107711 Jul2015 BLAKE¿SiliconeDrain 2234 J107715 Jul2015 BLAKE¿SiliconeDrain 2234 J107716 Jul2015 BLAKE¿SiliconeDrain 2234 J108694 Jul2015  The below lots were added on May 9, 2011 and Ethicon sent out another recall letter BLAKE¿ Silicone Drains lot J1015422 of product code 2234, and lot J1010652 of product code 2227
Recalling Firm/
Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
For Additional Information Contact Ms. Melissa Day
Manufacturer Reason
for Recall
There is a potential for the sterile barrier to be compromised in multiple lots of Blake silicone drains, Blake silicone drain kits, Blake cardio connectors, J-VAC reservoirs, J-VAC drain adaptors.
FDA Determined
Cause 2
Packaging process control
Action Ethicon, Inc. sent an "URGENT VOLUNTARY PRODUCT RECALL" letter dated March 24& 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue use of the products and to return the products to Stericycle. The letter includes shipping labels for product return. Ethicon will send replacement product. Customers are asked to return a completed Business Reply Card to Stericycle regardless of whether or not they have the products subject to this recall. Customers with questions regarding this recall are directed to call 1-866-664-1401.
Quantity in Commerce 846,990
Distribution Worldwide Distribution-- USA (nationwide) and Puerto Rico and the countries of Armenia, Australia, Austria, Azerbaijan, Columbia, Cyprus, Czech Republic, Denmark, French Guinea, French Polynesian, Germany, Israel, Italy, Japan, Kuwait , Netherlands, New Caledonia, New Zealand, Norway, Singapore, Slovenia, South Africa, Spain, Belarus, Belgium, Brazil, Canada, Chile, Dominica Republic, Egypt, Estonia, Finland, France, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Latvia, Lithuania, Malaysia, Martinique, Mozambique, Portugal, Reunion, Russia, Saudia Arabia, Sweden, Switzerland, Ukraine, and United Kingdom.

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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KOG and Original Applicant = JOHNSON & JOHNSON MEDICAL, INC.