Class 2 Device Recall GIBCO CTS AIM V SerumFree Media (SFM

• Date Initiated by Firm: May 10, 2018
• Date Posted: July 25, 2018
• Recall Status: Terminated on May 05, 2020
• Recall Number: Z-2543-2018
• Recall Event ID: 80380
• 510(K)Number: K022086
• Product Classification: Media, culture, ex vivo, tissue and cell - Product Code NDS
• Product: GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.
• Code Information: Lot: 1923698
• FEI Number: 1317268
• Recalling Firm/ Manufacturer: Life Technologies, Corp.; 3175 Staley Rd; Grand Island NY 14072-2028
• For Additional Information Contact: Sandra Kuligowski; 716-774-6677
• Manufacturer Reason for Recall: It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: Urgent Medical Device Recall Notification letters dated 6/28/18 were distributed to customers to notify them of the recall of GIBCO CTS AIM V Serum-Free Media (SFM); Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate; Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose; and Gibco RPMI 1640 Medium. The letters instructed customers to do the following: For the above mentioned lots of product, please complete an inspection of the seal integrity of your inventory. There should not be visual evidence of media within the space between the media bag itself and the dust cover. If you are using product that was manufactured between the dates noted above and you have confirmed media between the media bag and dust cover, we ask that you dispose of these bags per local and state requirements and complete the attached Customer Response Form. As noted above, for bags that do not have any visible media beyond the seal, we have confirmed through sterility testing that these units meet sterility specifications and are acceptable for use. Please inform all affected users within your organization of this notification. If you have used this product in manufacturing, you must notify impacted customers and impacted facilities of this notice and our concern for the potential of fill tube seal integrity loss. Please complete the following Customer Response Sheet if you have product that was manufactured between September 2017 and December 2017 and you have confirmed visual evidence of media between the media bag and dust cover. We will work with you to ensure that you receive credit for the discarded material. North American customers: Please complete the following Customer Response Sheet if you have confirmed visual evidence of at the bag-port or media between the media bag and dust cover in your material. Email a scanned copy of the response sheet along with this letter to customer.relations@thermofisher.com. If you have any questions, please ca
• Quantity in Commerce: 141
• Distribution: Worldwide distribution. US states: CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA., Canada, France, Great Britain, Japan, Korea, Netherlands, and Switzerland.
• 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 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 = NDS