Class 4 Drug Alert, certain Baxter Potassium Chloride containing intravenous infusions
Baxter Healthcare Limited has informed us that a quality defect has been identified with the above product where the front panel of a small number of infusion bags was found to be missing the red text.
Company name
Baxter Healthcare Limited
Product description
Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion – BP, 1000ml, Product code FKE1764 (PL 00116/0336)
Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Solution for Infusion, 1000ml, Product Code FKE1984 (PL 00116/0337)
Potassium Chloride 0.15% w/v and Glucose 10% w/v Solution for Infusion, 500ml Product Code FE3737 (PL 00116/0656)
Brief description of the problem
Baxter Healthcare Limited has informed us that a quality defect has been identified with the above products where the front panel of a small number of infusion bags was found to be missing the red text.
The red text highlights the presence of potassium chloride in the products formulation which is a risk-mitigating factor in the prevention of a potential mix-up with other solutions for infusion. See Appendix 2 in the pdf attachment for correct label texts.
Advice for healthcare professionals
- Please check your complete inventory of the above products and inspect the print on each bag to ensure the presence of the red print. This includes stock within your pharmacy, on wards and at any other relevant location within your hospital
- Please consider the possibility that the absence of red text may have resulted in units being stored in the incorrect location so please ensure that all locations where infusion bags are stored are checked.
- If units have been supplied to any other facilities or departments within your institution, please forward a copy of this letter to them.
- If you have any home patients who use these products, please notify them.
Further information
Should any units be identified without the red print, please place those units in quarantine and notify Baxter by email: uk_shs_qa_complaints@baxter.com or by telephone: 01604 704 603 (Baxter reference number: FA-2019-026).
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone 020 3080 6574
Appendix 1: Tables of affected batches
Potassium Chloride 0.15% w/v and Glucose 10% w/v Solution for Infusion, 500ml, PL 0116/0656, Product Code FE3737. Distributed from August 2017
| Batch | Manufacture Date | Expiry Date |
|---|---|---|
| 17H11T2G | 11/08/2017 | Jul-19 |
| 17L01T2F | 01/12/2017 | Nov-19 |
| 18C26T2C | 26/03/2018 | Feb-20 |
| 18C26T2CA | 26/03/2018 | Feb-20 |
| 18C26T2CB | 26/03/2018 | Feb-20 |
| 18I24T2H | 24/09/2018 | Aug-20 |
| 18J08T2A | 08/10/2018 | Sep-20 |
| 19D10T2C | 10/04/2019 | Mar-21 |
Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion – BP, 1000ml, PL 00116/0336, Product Code FKE1764. Distributed from August 2016
| Batch | Manufacture Date | Expiry Date |
|---|---|---|
| 16G13T2C | 13/07/2016 | Jun-19 |
| 16H03T1F | 03/08/2016 | Jul-19 |
| 16J10T1B | 10/10/2016 | Sep-19 |
| 16L12T1D | 12/12/2016 | Nov-19 |
| 17A26T2D | 26/01/2017 | Dec-19 |
| 17D25T1G | 25/04/2017 | Mar-20 |
| 17E31T1B | 31/05/2017 | Apr-20 |
| 17H22T2G | 22/08/2017 | Jul-20 |
| 17I28T2C | 28/09/2017 | Aug-20 |
| 17L02T1B | 02/12/2017 | Nov-20 |
| 17L22T2G | 22/12/2017 | Nov-20 |
| 18B02T1B | 02/02/2018 | Jan-21 |
| 18B02T1B | 02/02/2018 | Jan-21 |
| 18B03T1H | 03/02/2018 | Jan-21 |
| 18D06T1G | 06/04/2018 | Mar-21 |
| 18E15T2E | 15/05/2018 | Apr-21 |
| 18E15T2EA | 15/05/2018 | Apr-21 |
| 18G05T1C | 05/07/2018 | Jun-21 |
| 18H21T2D | 21/08/2018 | Jul-21 |
| 18I18T1E | 18/09/2018 | Aug-21 |
| 18J03T1F | 03/10/2018 | Sep-21 |
| 18K05T2C | 05/11/2018 | Oct-21 |
| 18K21T2H | 21/11/2018 | Oct-21 |
| 18L20T1D | 20/12/2018 | Nov-21 |
| 19B03T1E | 03/02/2019 | Jan-22 |
| 19D05T2A | 05/04/2019 | Mar-22 |
Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Solution for Infusion, 1000ml, PL 00116/0337, Product Code FKE1984. Distributed from September 2016
| Batch | Manufacture Date | Expiry Date | ||
|---|---|---|---|---|
| 16H02T1B | 02/08/2016 | Jul-19 | ||
| 16I15T1B | 15/09/2016 | Aug-19 | ||
| 16J18T1A | 18/10/2016 | Sep-19 | ||
| 16K21T1D | 21/11/2016 | Oct-19 | ||
| 16L19T2G | 19/12/2016 | Nov-19 | ||
| 17B03T1D | 03/02/2017 | Jan-20 | ||
| 17B03T1DA | 03/02/2017 | Jan-20 | ||
| 17C15T2E | 15/03/2017 | Feb-20 | ||
| 17D18T1B | 18/04/2017 | Mar-20 | ||
| 17D18T1BA | 18/04/2017 | Mar-20 | ||
| 17E09T1B | 09/05/2017 | Apr-20 | ||
| 17F06T1F | 06/06/2017 | May-20 | ||
| 17G11T2A | 11/07/2017 | Jun-20 | ||
| 17I19T2A | 19/09/2017 | Aug-20 | ||
| 17K08T1H | 08/11/2017 | Oct-20 | ||
| 17L13T2B | 13/12/2017 | Nov-20 | ||
| 18A05T2B | 05/01/2018 | Dec-20 | ||
| 18A31T1B | 31/01/2018 | Dec-20 | ||
| 18B14T2C | 14/02/2018 | Jan-21 | ||
| 18C09T1G | 09/03/2018 | Feb-21 | ||
| 18D19T2B | 19/04/2018 | Mar-21 | ||
| 18D30T1F | 30/04/2018 | Mar-21 | ||
| 18E21T2C | 21/05/2018 | Apr-21 | ||
| 18F12T1G | 12/06/2018 | May-21 | ||
| 18F12T1GA | 12/06/2018 | May-21 | ||
| 18F19T1F | 19/06/2018 | May-21 | ||
| 18G19T1F | 19/07/2018 | Jun-21 | ||
| 18H29T2C | 29/08/2018 | Jul-21 | ||
| 18I19T1C | 19/09/2018 | Aug-21 | ||
| 18J17T2H | 18/10/2018 | Sep-21 | ||
| 18J24T2H | 24/10/2018 | Sep-21 | ||
| 18K20T2H | 20/11/2018 | Oct-21 | ||
| 18K25T2G | 25/11/2018 | Oct-21 | ||
| 19A07T1C | 07/01/2019 | Dec-21 | ||
| 19B04T2E | 04/02/2019 | Jan-22 | ||
| 19B18T2C | 18/02/2019 | Jan-22 | ||
| 19C19T2A | 19/03/2019 | Feb-22 | ||
| 19D07T2H | 07/04/2019 | Mar-22 |
Download the document
Note: see document below for more details including images of affected batches.