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Recall Observatory FDA recall evidence

Device product

PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory

Z-2127-2017

April 21, 2017

Class II

Product summary

Firm
Teleflex Medical
Event
Event 77081
Status
Terminated
Classification
Class II
Quantity
19,043 units in total
Official record key
device-enforcement:Z-2127-2017

Official wording

Reason: Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.

Code information: Product Code: PE100, Lot numbers: 02F0801115, 02F0901859, 02G0802748, 02G0900814, 02H0900192, 02K0900567, 02L0900163, 02M0901006, 74A1601695, 74G1500137, 74G1502714 & 74M1400489.

Distribution pattern: Worldwide Distribution - U.S. Nationwide. Foreign consignees: Australia, Canada, China, Columbia, India, San Salvador, Singapore and South Korea.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.