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Recall of multiple products - potential for breaches of sterile packaging

25 January 2019

Consumers and health professionals are advised that ConvaTec Australia, in consultation with the TGA, is recalling multiple products after tests found that the sterile packaging could be breached during transport.

Products affected include suction tubes/catheters, oxygen delivery catheters, gastro-enteral tubes, nasogastric tubes, intermittent urology catheters, drainage kits and sterile urine drainage bags.

The affected products have the following Australian Register of Therapeutic Goods (ARTG) numbers:

ARTG number Product category
185736 Rectal Tube
185738 Oxygen Delivery Catheter, Nasal
185748 Wound Drainage Kit
185751 Urethral Drainage Catheter
185770 General Purpose Suction Tip
185783 Nasogastric Tube
187327 Urine Collection Bag, Open-ended
219377 Enteral Suction Tube
223901 Tracheal Suction Catheter

Transportation testing conducted on the product packaging showed that the packaging integrity was not meeting performance expectations, confirming that there is the potential for a breach in the sterile barrier during transport of these devices. Using a non-sterile device on a patient may expose the patient to infectious agents, increasing the risk of the patient developing an infection.

To date, ConvaTec has not received any reports of incidents related to this packaging issue.

All products supplied to hospitals and distributors since 1 January 2018 are included in this recall.

Information for consumers

If you, or somebody you provide care for, has been supplied with a ConvaTec Australia product, please be alert to this issue. Contact the supplying health facility as soon as possible to check if it is affected by this recall and, if so, to arrange for replacement with an alternative product.

Information for health professionals and facilities

ConvaTec Australia has written to all facilities that have been supplied with affected products providing further information about this issue, including details of the recall process. Health facilities which have supplied affected products to patients should contact the patients or their carers and arrange for replacement.

Facilities should note that any affected product supplied within a procedure pack is not subject to this recall action, because procedure packs are sterilised a second time in licenced facilities as part of their manufacture. However, due to this anomaly, in the event affected product is not used after the procedure pack has been opened, those items should be discarded and not re-stocked for later use.

If you have any questions or concerns about this issue, contact ConvaTec Australia on 1800 339 412.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information, see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.