CLASS III Device recall · Reported 7 Jun 2017 · FDA Enforcement Report
Nutrient Gelatin, Acumedia recalled by Acumedia Manufacturers
Acumedia Manufacturers is recalling Nutrient Gelatin, Acumedia, distributed nationwide in the US. The recall was initiated on 23 Mar 2016 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2213-2017
- FDA event ID
- 77275
- Recalling firm
- Acumedia Manufacturers, Lansing, MI
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 23 Mar 2016
- FDA classified
- 1 Jun 2017
- Reported
- 7 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 23 Mar 2016 | Recall initiated by company | |
| 1 Jun 2017 | Classified by FDA | +435 days |
| 7 Jun 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016. Product was labeled with expiration date of April 30, 2018.
Product as listed by the FDA
Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is present, gelatin is hydrolyzed and loses its gelling characteristic.
Where it was distributed
Worldwide - US Nationwide in the state of ME; in the country of ECUADOR
Questions about this recall
Is Nutrient Gelatin, Acumedia recalled?
Yes. Acumedia Manufacturers recalled Nutrient Gelatin, Acumedia on 23 Mar 2016. The recall is Class III and its status is Terminated. Recall number Z-2213-2017.
Why was it recalled?
Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016. Product was labeled with expiration date of April 30, 2018.
Which lots are affected?
PN 7471A, Lot 105550F
Where was it sold?
Worldwide - US Nationwide in the state of ME; in the country of ECUADOR
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Acumedia Manufacturers
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Campylobacter Blood Free Selective Medium recalled | Acumedia Manufacturers | Other | Nationwide |
| Device | CLASS III | Palcam Agar Base, Acumedia, PN recalled by Acumedia Manufacturers | Acumedia Manufacturers | Listeria | Nationwide |
| Device | CLASS II | Palcam Supplement Acumedia PN recalled by Acumedia Manufacturers | Acumedia Manufacturers | Listeria | Nationwide |
| Device | CLASS III | Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used recalled | Acumedia Manufacturers | Temperature Abuse | Nationwide |
| Device | CLASS III | Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN recalled | Acumedia Manufacturers | Temperature Abuse | IL |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |