Health Canada announces that certain lots of Baxter intravenous solution bags have the potential to leak during the process of spiking the administration port. However, the following affected products identified are not being recalled at this time in order to prevent a shortage of these medically necessary products in Canada.
The affected products are:
- 0.4% Lidocaine & 5% Dextrose Injection (250ml) (lot number: W3E11C1)
- Lactated Ringer’s Injection, USP (250ml) (lot number: W3F22C1)
- Metronidazole Injection, 500mg/100ml, USP (100ml) (lot number: W3E30C1)
- 0.9% Sodium Chloride Injection, USP (100ml) (lot number: W3D25C0, W3D26C0, W3D29C2, W3E03C0, W3E04C0, W3E09C0. W3E18C0, W3E30C0, W3F06C0, W3F13C0, W3F21C0, W3F28C0, W3F29C0, W3G11C0, W3G12C0, W3G13C0, W3G17C3, W3G18C0)
- 0.9 % Sodium Chloride Injection, USP (250ml) (lot number: W3D24B0, W3D27C0, W3E01B0, W3E02B0, W3E05C1, W3E10B0, W3E13C1, W3E15B1, W3E16B0, W3E25C2, W3F01C0, W3F01C0S, W3F02C1, W3F05B0, W3F12B0, W3F14C0, W3F16B0, W3F19B0, W3F20B0, W3F21B0KX, W3F21B0X, W3F22C0, W3F30C0, W3G10B0, W3G11B0, W3G12B0K, W3G12B0X, W3G14C0,W3G15C0, W3G17B0, W3G17B0S, W3G18B0, W3G18B0S)
Healthcare professionals are advised to:
- NOT use the product if the defect is observed.
- Follow guidance on the handling and verification of affected products (see the “Information for healthcare professionals” section) and
- Ensure preparedness at points of use where affected products are identified.
Health Canada also advised to avoid using the affected lots when feasible, particularly in situations requiring immediate product use (e.g., operating room, critical care and emergency). If only products from affected lots are available, additional measures should be considered, including the immediate supply of replacement bags at point of use and additional safety measures based on professional practice.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/baxter-intravenous-solution-bags-potential-leak-during-spiking-administration-port
In Hong Kong, the following pharmaceutical products are registered by Baxter Healthcare Ltd (Baxter):
- Sodium Chloride Inj 0.9% (Baxter) (HK-20984)
- 0.9% Sodium Chloride Injection (HK-58996)
- 0.9% Sodium Chloride Injection, USP in Mini-bag Plus Container (HK-61943)
- Sodium Chloride Solution For Infusion 0.9% w/v in Aviva Container (HK-62220)
- Sodium Chloride Solution For Intravenous Infusion 0.9% w/v (HK-64733)
- Lactated Ringer's Inj USP (Baxter) (HK-41322)
- Metronidazole IV Infusion 0.5% (Baxter) (HK-40240)
The above products are prescription-only medicines. 0.4% Lidocaine & 5% Dextrose Injection mentioned in the Health Canada’s announcement is not a registered pharmaceutical product in Hong Kong. Baxter has been contacted regarding the above issue and their reply is pending.
Ends/Saturday, Oct 7, 2023
Issued at HKT 14:00
As confirmed with Baxter, the affected lots have not been imported into Hong Kong.
Content last updated: Monday, Oct 9, 2023 |
