CLASS II Drug recall · Reported 29 Aug 2012 · FDA Enforcement Report
Custom Access Tray, Sterile, contains Sodium Chloride recalled
Custom Medical Specialties is recalling Custom Access Tray, Sterile, contains Sodium Chloride 9%, Re-order #: CMS-1667-R2(94-2478), distributed in Georgia, Massachusetts, Maryland. The recall was initiated on 23 Jul 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1649-2012
- FDA event ID
- 62775
- Recalling firm
- Custom Medical Specialties, Pine Level, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jul 2012
- FDA classified
- 17 Aug 2012
- Reported
- 29 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- FAX
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Jul 2012 | Recall initiated by company | |
| 17 Aug 2012 | Classified by FDA | +25 days |
| 29 Aug 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description.
Where it was distributed
GA, MD, MA
Questions about this recall
Is Custom Access Tray, Sterile, contains Sodium Chloride 9%, Re-order #: CMS-1667-R2(94-2478) recalled?
Yes. Custom Medical Specialties recalled Custom Access Tray, Sterile, contains Sodium Chloride 9%, Re-order #: CMS-1667-R2(94-2478) on 23 Jul 2012. The recall is Class II and its status is Terminated. Recall number D-1649-2012.
Why was it recalled?
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags
Which lots are affected?
Lot #: 25744-1111, Exp 09/2012
Where was it sold?
GA, MD, MA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Custom Medical Specialties
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cms-2193-R7 and Cms-1911-R3 Custom Biopsy Tray recalled | Custom Medical Specialties | Sterility | ID, OR |
| Device | CLASS II | US Probe Cover CMS-6049, Sterile, Single Patient Use recalled | Custom Medical Specialties | Sterility | 9 states |
| Device | CLASS I | CMS-5284 Custom Myelogram Tray containing bottle PVP Prep Solution recalled | Custom Medical Specialties | Other | Nationwide |
| Device | CLASS I | CMS-8495-R5 Custom Vein Tray containing bottle PVP Prep Solution recalled | Custom Medical Specialties | Other | Nationwide |
| Device | CLASS I | Cms-8325-R2 Abington Radiology Drainage Pack recalled | Custom Medical Specialties | Other | Nationwide |