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Recall Observatory FDA recall evidence

Device product

Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.

Z-1497-2014

March 11, 2014

Class II

Product summary

Firm
Teleflex Medical
Event
Event 67895
Status
Terminated
Classification
Class II
Quantity
3,816 ea
Official record key
device-enforcement:Z-1497-2014

Official wording

Reason: The products are being recalled because they did not meet minimum diameter requirements.

Code information: Product Code: 0520197-2, Lot number: 02H1001071; Product Code: 29-727, Lot numbers: 02M1101954, 02C1201003, and 02C1201646; Product Code: 29-7270M4, Lot number: 02D1100604; Product Code: 29-7281M4, Lot number: 02M1002679; Product Code: E29-5553M4, Lot number: 02B1300245; Product Code: E29-7270M4, Lot number: 02J1001576; Product Code: E29-7272M4, Lot number: 02D1003015; Product Code: E29-727A, Lot number: 02F1101062; Product Code: EP4013P, Lot number: 02L0800898; Product Code: EP4110N, Lot number: 02H0900483; Product Code: X-2235, Lot numbers: 02E1102068, 02F1101041, 02F1201500, and 02G1201230; Product Code: X29-7271M2, Lot number: 02K1100784; Product Code: X-5667M8 and Product Code: X-6730M5, Lot number: 02G1300492.

Distribution pattern: Worldwide Distribution - CA, CO, FL, IN, KY, MA, NM, PA, Canada, Ireland and Germany.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The products are being recalled because they did not meet minimum diameter requirements.