The Patient Control Module — Class II medical device recall Z-1536-2015
Terminated recall by Baxter Healthcare Corp., reported 2015-05-06, distributed in FL. Potential for device malfunction resulting in flow when the device should not be flowing
| Recall number | Z-1536-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2014-04-17 |
| Classified | 2015-04-27 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2017-07-21 |
| Distributed | FL |
| Countries outside the US | AE, BE, DE, DK, ES, IT, JP, KR, NO, PL, SE |
| Quantity | 7,596 patient |
| Reason classes | device malfunction |
| Lot numbers | 11D001, 11D068, 11E025, 11E048, 11E084, 11F050, 11G019, 11H019, 11H035, 11H074, 11J042, 11J078, 11M078, 11N025, 11N027, 12A020, 12A037, 12A050, 12A095, 12B040, 12C033, 12D016, 12D041, 12D061, 12D089, 12E004, 12F010, 12F012, 12F036, 12G032, 12G034, 12G057, 12H012, 12H033, 12H077, 12J047, 12K008, 12K024, 12M036, 12N031 and 22 more |
| Expiration dates | 2014-04-01, 2014-05-01, 2014-05-31, 2014-06-01, 2014-07-01, 2014-08-01, 2014-08-31, 2014-09-01, 2014-11-01, 2014-12-01, 2014-12-31, 2015-01-01, 2015-02-01, 2015-03-01, 2015-04-01, 2015-04-30, 2015-05-01, 2015-06-01, 2015-07-01, 2015-08-01, 2015-09-01, 2015-10-01, 2015-10-31, 2015-11-01, 2015-12-01 and 16 more |
Product
The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.
Reason for recall
Potential for device malfunction resulting in flow when the device should not be flowing
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1536-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.