Aesculap Elan 4 Duraguard Surgical Instruments Mislabeled Long and Standard
Aesculap AG recalled three Elan 4 Fixed Duraguard surgical instruments that were mislabeled. Units marked 'Long' were actually 'Standard' and vice versa, which could affect surgical procedures.
What this means for you
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: This is a Class II mislabeling recall of surgical instruments with no reported injuries or illnesses. Mislabeling of surgical instruments represents a risk-of-harm scenario where using the incorrect size could affect patient safety during procedures, meeting the rubric criterion for High (Score 3) severity.
Plain-English summary
Aesculap AG has recalled three units of the Elan 4 Fixed Duraguard surgical instruments (Model GB943R, UDI-DI 04046963805784). The recalled units have the following serial numbers: 4519, 4528, and 4533.
The instruments were affected by mislabeling: units labeled as 'Standard' were actually 'Long,' and units labeled as 'Long' were actually 'Standard.' This labeling error could result in surgeons selecting and using the wrong size instrument during surgical procedures.
In the United States, the affected instruments were distributed to Missouri. Internationally, they were distributed to Norway, Portugal, France, Great Britain, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, and Thailand.
Healthcare facilities that received these instruments should verify receipt against the serial numbers provided and confirm the correct sizing before use in surgical procedures. Contact Aesculap AG for further instructions regarding return or replacement of the affected units.
The recalled product
- Product
- AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
- Manufacturer
- Aesculap AG
- Hazard
- mis-labeling
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 (4)
- Model Number: GB943R
- UDI-DI Number: 04046963805784. Serial Numbers: 4519
- 4528
- 4533.
Distribution
Distribution scope not specified by the agency.
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