Company led drug alert - Macopharma intravenous infusion bags
Macopharma is recalling certain batches of intravenous infusion bags as a precaution. This is due to the detection of metal particles in two infusion bags.
CLDA Number
CLDA (19)A/03
MDR Number
MDR 59-04/19
Company name
Macopharma
Product description
Various intravenous infusion bags, see list below
Batch Number/ Expiry
See list below
PL Number: PL12580/0008
| PRODUCT | BATCH | Expiry Date |
|---|---|---|
| NACL 0,9% 250ML MACOFLEX | 17F15A | Apr 2020 |
| NACL 0,9% 250ML MACOFLEX | 17F23B | Apr 2020 |
| NACL 0,9% 250ML MACOFLEX | 17L08B | Apr 2020 |
| NACL 0,9% 250ML MACOFLEX | 18B20C | Apr 2020 |
| NACL 0,9% 250ML MACOFLEX | 18C08C | Apr 2020 |
| NACL 0,9% 250ML MACOFLEX | 18D05A | Apr 2020 |
| NACL 0,9% 250ML MACOFLEX | 18E23A | May 2020 |
| NACL 0,9% 250ML MACOFLEX | 18F08B | Jun 2020 |
| NACL 0,9% 250ML MACOFLEX | 18G10A | Jul 2020 |
| NACL 0,9% 250ML MACOFLEX | 18G11A | Jul 2020 |
| NACL 0,9% 500ML MACOFLEX | 17L03A | Apr 2020 |
| NACL 0,9% 500ML MACOFLEX | 17L13B | Apr 2020 |
| NACL 0,9% 500ML MACOFLEX | 18A16C | Apr 2020 |
| NACL 0,9% 500ML MACOFLEX | 18A24A | Apr 2020 |
| NACL 0,9% 500ML MACOFLEX | 18A25A | Apr 2020 |
| NACL 0,9% 1000ML MACOFLEX | 18B06A | Apr 2020 |
| NACL 0,9% 1000ML MACOFLEX | 18B08B | Apr 2020 |
| NACL 0,9% 1000ML MACOFLEX | 18B21B | Apr 2020 |
| NACL 0,9% 1000ML MACOFLEX | 18B22B | Apr 2020 |
| NACL 0,9% 1000ML MACOFLEX | 18B23A | Apr 2020 |
| NACL 0,9% 1000ML MACOFLEX | 18C20A | Apr 2020 |
| NACL 0,9% 1000ML MACOFLEX | 18D04A | Apr 2020 |
PL Number: PL12580/0007
| PRODUCT | BATCH | Expiry Date |
|---|---|---|
| GLUCOSE 10% 500ML MACOFLEX | 17K29A | Apr 2020 |
| GLUCOSE 10% 500ML MACOFLEX | 18E12A | May 2020 |
PL Number: PL12580/0020
| PRODUCT | BATCH | Expiry Date |
|---|---|---|
| RINGER LACTATE 500ML | 18C26A | Apr 2020 |
| RINGER LACTATE 500ML | 18D28A | Apr 2020 |
| RINGER LACTATE 500ML | 18F16A | Jun 2020 |
| RINGER LACTATE 1000ML | 18B24A | Apr 2020 |
| RINGER LACTATE 1000ML | 18C27A | Apr 2020 |
| RINGER LACTATE 1000ML | 18C28A | Apr 2020 |
| RINGER LACTATE 1000ML | 18F23A | Jun 2020 |
PL Number: PL12580/0006
| PRODUCT | BATCH | Expiry Date |
|---|---|---|
| GLUCOSE 5% 250ML EASYFLEX N | 18F01A | May 2020 |
| GLUCOSE 5% 500ML EASYFLEX N | 18D12B | Apr 2020 |
PL Number: PL12580/0006
| PRODUCT | BATCH | Expiry Date |
|---|---|---|
| GLUCOSE 5% 250ML MACOFLEX | 17I15A | Apr 2020 |
| GLUCOSE 5% 250ML MACOFLEX | 18B16A | Apr 2020 |
PL Number: PL12580/0008
| PRODUCT | BATCH | Expiry Date |
|---|---|---|
| NACL 0,9 %500 ML Easyflex N | 18E16A | Apr 2020 |
| NACL 0,9% 1000ML Easyflex N | 17F14A | Apr 2020 |
| NACL 0,9% 250ML | 17J26B | Apr 2020 |
| NACL 0,9% 250ML | 18E17A | May 2020 |
Brief Description of Problem
Macopharma is recalling certain batches of intravenous infusion bags as a precaution, see list above. This is due to the detection of metal particles in two infusion bags. No incidents have been reported in the UK. We understand these products have a fast turnover and that affected batches were delivered through 2017 with the last batch delivered in November 2018. Although it is unlikely that there is much stock remaining in the supply chain, please check your inventory and quarantine any affected stock then notify Macopharma Customer Services, see details below.
Company contact for stock enquiries
Macopharma Customer Services:
T: 01332 206022
Company Contact for medical information enquiries
Customer Services as above or clive.richards@spiritmedical.com