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Recall Observatory FDA recall evidence

Device product

Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile.

Z-2229-2024

March 14, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94239
Status
Ongoing
Classification
Class II
Quantity
7,673 total non-sterile kits
Official record key
device-enforcement:Z-2229-2024

Official wording

Reason: Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Code information: a. Pack #DYNJ901130I - Lot numbers 23GMH075, exp. 7/31/2024, and 23GMD605, exp. 7/31/2024, UDI-DI each-10193489946055 and UDI-DI case-40193489946056. b. Pack DYNJ902938J - Lot numbers 23LMD530, 23IMG375, 23HMB336, 23GMF342, 23EMJ935, and 23EMK254, all exp. date 8/31/2024, UDI-DI each-10193489946116, UDI-DI case 40193489946117.

Distribution pattern: US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach in sterility