Medline—​BD Vacutainer SST Plus Blood Collection Tubes: Stopper May Not Meet Manufacturing Specifications

July 8, 2015 | Risk Management News

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ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In a June 29, 2015, Immediate Action Required letter submitted by an ECRI Institute member hospital, Medline initiated a subrecall of the blood collection tubes below that were recalled by BD because the stoppers did not meet manufacturing specifications. Medline states that analytical studies performed on stoppers with reduced cure time demonstrated no differences compared with stoppers that are currently used for manufacturing SST tubes, indicating no health risk. It is not expected that the stoppers with reduced cure time would affect laboratory test results. Medline further states that no adverse events related to this problem have been reported. The distributor or manufacturer has not confirmed...

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