Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
FDA Recall Z-0091-2019 · Posted None
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Recalling FirmReckitt Benckiser LLC
Recall StatusTerminated
Product CodeMOL
Date Initiated2018-08-06
Date Terminated2019-11-12
Product Quantity34 cartons/12 condoms each (408 condoms total)
Reason for Recall
Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
Firm Action
On August 6,. 2018, Reckitt Benckiser issued Urgent Medical Device Recall notices to customers. Customers were advised to take the following action:
Wholesale Customers:
1. Examine inventory and quarantine affected product
2. Contact customers and notify them of the recall and provide them with the recall instructions (copy of the letter).
3. Customers are encouraged to contact Stericycle Expert Solutions at 877-448-5308 for assistance if additional return labels are required or help with coordination of pickup and removal of product from your facility.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US in the states of NY
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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