The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0178-2015·Announced 2014-11-12

Dokitz NovoSci Recalls Cardiopulmonary Bypass Connectors Due to Detachment Risk

Dokitz NovoSci is recalling 240 units of cardiopulmonary bypass connectors because the single leg of the PAY connector has been observed to become detached.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (detachment) that poses a risk of harm during a critical procedure, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Dokitz NovoSci is recalling 240 units of cardiopulmonary bypass connectors (P/N: 321334-000, Lot: 295424). The recall is due to reports that the single leg of the PAY connector has been observed to become detached.

The affected units were manufactured in May 2014 and have an expiration date of May 2019. These sterile connectors were distributed to facilities in Missouri, Texas, Pennsylvania, Illinois, Maryland, and Utah.

Healthcare facilities should stop using the affected connectors and contact Dokitz NovoSci for further instructions. Consumers are not expected to have these products in their homes.

The recalled product

Product
Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
Manufacturer
Dokitz NovoSci
Category
Medical Device — Cardiopulmonary Bypass
Hazard
Affected units
240

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model No. 321334-000
  • lot number 295424

Distribution

Distributed in 6 states:

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