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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70430

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 08, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bard Access Systems

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline BARD MYPICC KIT (4F) (Single Lumen), Groshong NXT Catheter 5F Maximal Barrier Tray (Dual-Lumen) (with MicroIntroducer) , Groshong NXT BARD MYPICC KIT (5F) (Dual-Lumen) (45cm), PowerPICC Catheter 5F Full Tray (Single-Lumen), PowerPICC Catheter 5F Maximal Barrier Tray (Single-Lumen), Poly Per-Q-Cath Catheter 3F Single-Lumen Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter 4F Single-Lumen Full Tray (with Mircrointroducer), Poly Per-Q-Cath 5F Dual-Lumen Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter 3F Full Tray (Single-Lumen) (with Microintroducer) (60cm), Poly Per-Q-Cath Catheter 4F Full Tray (Single-Lumen) (with Microintroducer) (60cm), Poly Per-Q-Cath Catheter 5F Full Tray (Dual-Lumen) (with Microintroducer) (60cm), Groshong NXT ClearVue 4F Catheter Full Tray (Single-Lumen) (60cm), Groshong NXT ClearVue 4F Catheter Full Tray (Single-Lumen) (60cm) (with Microintroducer), Groshong NXT ClearVue Catheter 4F Maximal Barrier Tray (Single-Lumen), PowerPICC 5F Dual-Lumen Polyurethane Catheter with MicroEZ Microintroducer Nurse Full Tray (with Lidocaine), PowerPICC Catheter 5F Maximal Barrier Tray with Microintroducer (Dual-Lumen), PowerPICC FT Catheter 5F Maximal Barrier Tray Tray (Dual-Lumen), PowerPICC Bard MYPICC Kit 5F (Dual-Lumen)(with Nitinol Guidewire)(70cm), PowerPICC Catheter 5F Maximal Barrier Tray (Dual-Lumen) (55cm) (with Microintroducer), PowerPICC Catheter 5F Full Tray (Dual-Lumen) (70cm Nitinol Guidewire) (with Microintroducer), PowerPICC Bard MYPICC Kit 5F (Dual-Lumen) RN, PowerPICC BARD MYPICC KIT (5F) (Dual-Lumen), PowerPICC Catheter 6F Full Tray (Triple-Lumen)(with Microintroducer) (with Lidocaine), PowerPICC HF Catheter 5F Full Tray (Triple-Lumen), PowerPICC HF Catheter 5F Maximal Barrier Tray (Triple-Lumen), PowerPICC Catheter 6F (Triple-Lumen) Maximal Barrier Tray, PowerPICC SOLO HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Triple-Lumen), PowerPICC HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Triple-Lumen), PowerPICC HF Bard MYPICC Kit 5F (Triple-Lumen), PowerPICC HF BARD MYPICC KIT (5F) (Triple-Lumen), PowerPICC HF Catheter Maximal Barrier Tray (5F) (Triple-Lumen) (55cm), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (Single-Lumen), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (Single-Lumen) (with Microintroducer), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen) (45cm), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen) (45cm) (with Microintroducer), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Maximal Barrier Tray (Single-Lumen), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Dual-Lumen) (45cm), Groshong NXT Sherlock II BARD MYPICC KIT (4F) (Single-Lumen) (TLS), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 3F Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray, Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray, Poly Per-Q-Cath Sherlock II Bard MYPICC KIT (4F) (Sinlge-Lumen) (TLS), Poly Per-Q-Cath Sherlock II BARD MYPICC KIT (4F) (Single-Lumen) (TLS), PowerPICC Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Single-Lumen) (with Microintroducer), PowerPICC 5F Dual-Lumen Polyurethane Catheter with Sherlock Tip L

Z-1271-2015
Recall number
Z-1271-2015
Initiated
August 08, 2014
Classification
Class II
Status
Terminated
Recalling firm
Bard Access Systems
Quantity
134,554 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.

Code information

Lot Numbers: REXE1224, REYD1858, REXE0422, REXE0501, REYD0765, REYE1330, REYE1453, REXE0428, REXE0469, 13GB3687, REXD1150, 13HB2925, REYD1851, REXD1127, REYD1730, REXE0436, REXD1121, REXE0504, REXD1122, REXD1480, REXE0488, REXD1105, REYE1981, REXD1100, REXD1512, REXE0416, REXE0423, REXD1424, REYD1853, REXE0442, REXD2228, REXE0506, REXE1249, REXE1244, 13GB5123, REXD2243, REXD2244, REXD2221, REXD1507, REXD1159, REXE0724, 13GB3809, 13GB9452, 13HB0439, REYE0422, REXE0432, REXE1238, REYD1734, REXD1437, REXE1227, REYE0567, REXE0443, REXE1228, REXD1426, REXE0502, REXE1248, REYD1746, REXD1499, REXD1489, REXE0414, REXD1134, 13SB2585, 13GB3742, 13HB0440, REYD1986, REYD0634, REXE0448, REXD1147, REYD0718, REXD2246, REXE1260, REYE0645, REXE0481, REXD1154, REYE1472, REXD1155, REXD2225, REXE1247, REXE1917, 13KB1321, REYD0709, REYD1414, REXD1442, REXE0430, REXE0484, REXD1140, REXE0580, REXD1449, REXE0699, 13GB4430, 13HB9983, 13GB4431, REYD1342, REXD1441, REXE0498, REXD1148, REXD1440, REXE0483, REXE1295, reyd0573, REXD2233, REYE1465, REXE0462, REYD0630, REYD1865, REYD1744, REXD1481, REXE0528, REXE0812, REXC1785, REYE1467, REYE0591, REYD1747, REXD1128, reyd0521, 13SB2581, 13GB3737, 13SB2582, 12GB0338A, 13SB2578, 13SB0587, REXE0444, REYE1349, REXE0452, REXE0427, REXE1240, 13GB5446, 13KB1324, 13GB6046, REYE0912, REYE0907, REXD1471, REXD1473, REXE0475, REXE0446, REXE1229, REXD1452, REYD1742, REXE1234, 13GB3736, REXD1509, 13GB3738, 13SB2579, 13GB3741, 13GB3744, REXE0323, REYF1101, REXE0464, REXD1478, REXE0445, REXE1221, REXE0447, REXD1153, REYE0440, REXE0465, REXE0489, REXE1257, REXD1139, REXD2237, REYE0566, REXE0503, REXD1418, REXD1158, REXD1496, REYD1346, REYD1419, REXD1466, REXE1243, REYD1743, REXC1788, REYE0443, REXD1143, REXD2241, REXD2240, REXE0479, REXE0480, REXE1252, REYE0589, REYD1745, REXD1156, REYD1869, REXD1492, REXD1132, REXD1485, REXE0421, 13HB3413, 13HB3992, 13FB1090, 13GB9453, 13GB3684, 13SB3169, 13GB3798, 13GB4432, 13GB3801, 13GB4429, REYE0782, REXE0435, REXE1232, REXD1125, REXE1169, REXE0545, REXE1311, REYD1840, REYE0553, REXE0470, REYE0554, REXD2223, REXE0482, REXD1505, REXD1470, REXE0458, REXE0543, REXD1497, REXC1861, REXE0524, REXE0525, REXE1291, REYE1312, REYE1435, REXE0438, REXE0473, REXE0544, REXD1417, REYD1400, REXD1490, REYE0919, REYE1314, REYE0778, REXD2234, REXE0449, REXE0450, REXE0451, REXD2235, REXE0536, REYE0776, REXD1486, REXE0431, REXE0472, REXE0471, REXE0546, REXE1219, REYD0750, REYD1721, REYE0556, REXD1502, REXD2222, REXE0499, REXE1226, REYE0916, REYE0915, REYE1318, REXD2238, REXD2239, REXE0493, REXE0494, REXE0492, REXE0491, REXE0813, REXE0540, REXE0490, REXE1268, REXD1464, REXD1463, REYD1846, REYE1442, REXE0329, REXE1231, REXE0728, REXE0460, REYE0913, REXE0420, REXE0522, REXE1298, REYE0771, REXD1484, REXE0453, REXE0533, REXE1299, REYE0910, REYE1970, REXD1453, REXD2245, REXE0500, REXE1261, REXD1119, REXD1501, REXE0413, REYE0909, REYE0768, REXD1488, REXE0326, REXE0415, REXE0527, REXE1434, REXD0772, REXE0425, REXE0495, REXE1264, REXD1112, REXE0060, 13HB6959, 13KB1325, 13SB2586, 13KB0543, 13FB1089, 13RB1247, 13GB3683, 13GB3799, 13KB1326, 13SB2584, 13GB3739, 13KB0542, 13GB3740, 13GB3802, 13KB0545, 13GB3804, 13GB0155, 13HB0438, 13FB2112, 13FB8861, 13GB3743, 13GB3808, 13SB0588, 13IB3041, 13GB3685, 13GB3686, 13FB8863, 13GB3806, 13GB3797, 13GB8905, 13HB0436, 13GB3794, 13GB3795, 13GB3735, 13GB3796, 13GB8906, 13GB4481, REXD2198, REXD2199, REYE1980, REXD2218, REXD2216, REXD2220, REXD2219, REYD1982, REYE1979, REYE1978, 13GB8904, 13SB0036, 13SB0585, REYD1407, REYE0439, REXE0017, REXD1465, 13SB2580, REXD1104, REYE1803. Product Codes: 4153108, , 4153108D, 4154108D, CK000119A, 7927508D, CK000050A, 3175108, 3175108D, 3153108, 3154108, 3255108, CK000108, CK000109, CK000110, 7617407, 7617408, 7617408D, 3275108, 3275108D, 3275108FD, CK000036, CK000057, CK000099, CK000111, CK000206, 3386108, 3385108Q, 3385108QD, 3386108D, 9385108Q, 9385108QD, CK000145A, CK000207, CK000293, 9617407, 9617408, 9827507, 9827508, 9617408d, 9827508d, CK000235, 9153108, 9154108, 9254108, 9255108, CK000150, CK000294, 9175108, 9275108, 9276108, 9175108d, 9275108d, 9275108F, 9386108d, 9386108QD, CK000021, CK000082, CK000134, CK000216, CK000218, 9818508, 9818508d, 9918508D, CK000204, CK000205, 3174108, 9174108, 3174108D, 9174108d, CK000080, CK000098, CK000143, CK000165A, CK000178, CK000214, CK000269, CK000335, 3194108, 3295108, 3396108, 9194108, 9295108, 3295108d, 3295108F, 3395108Q, 3395108QD, 3396108D, 9194108D, 9295108d, 9295108f, 9295108FD, 9395108Q, 9395108QD, CK000044, CK000061, CK000071A, CK000097, CK000137, CK000138, CK000201, CK000253, CK000245, 1174108, 1175108, 1194108, 1275108, 1295108, 1386108, 9396108, 1174108D, 1175108D, 1194108D, 1275108D, 1275108f, 1275108fd, 1295108D, 1295108f, 1295108fd, 1385108D, 1385108Q, 1385108QD, 1386108D, 1395108Q, 1395108QD, 1396108D, CK0000103, CK000025, CK000026A, CK000127, CK000128, CK000129, CK000142, CK000155, CK000169A, CK000184, CK000186, CK000187A, CK000188A, CK000191, CK000192, CK000194, CK000220, CK000221, CK000222, CK000228A, CK000231, CK000232, CK000233, CK000241, CK000242, CK000252, CK000266, CK000267, CK000268, CK000283, CK000287, CK000291, CK000295, CK000296, CK000297, 3173108, 9173108, 3274108D, 9274108D, CK000215

Distribution pattern

US Nationwide Distribution.

device · product 2 of 5

BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in, PowerLoc Port Access Kit 22G x 0.75in, , PowerLoc Port Access Kit 19G x 1 in with Y-Site, , , PowerLoc Port Access Kit 19G x 0.75in with Y-Site, PowerLoc Port Access Kit 20G x 1 in with Y-Site, PowerLoc Port Access Kit 20G x 0.75in with Y-Site The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.

Z-1272-2015
Recall number
Z-1272-2015
Initiated
August 08, 2014
Classification
Class II
Status
Terminated
Recalling firm
Bard Access Systems
Quantity
16,410 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.

Code information

Lot Numbers: REYE1714, REYE1713, REXD1617, REXE0089, REXE0077, REYE1233, REXE0085, REXE0971, REYE1709, REYE1579, REXD2157, REYE1269, REXD1932, REXE0826, REXE0086, REXD2155, REXD2156, REXE0697. Product codes: 2651910, 2652010, 2652015, 2652034, 2652210, 2652234, 2671910, 2671934, 2672010, 2672034.

Distribution pattern

US Nationwide Distribution.

device · product 3 of 5

BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit 20G x 0.75in with Y-Site, SafeStep Port Access Kit 20G x 1 in , SafeStep Port Access Kit 20G x 1 in with Y-Site, SafeStep Port Access Kit 19G x 0.75in , SafeStep Port Access Kit 19G x 0.75in with Y-Site, SafeStep Port Access Kit 19G x 1 in , SafeStep Port Access Kit 19G x 1 in with Y-Site, SafeStep Port Access Kit 20G x 1.5in , SafeStep Port Access Kit 20G x 1.5in with Y-Site, MiniLoc Port Access Kit 20G x 1 in, MiniLoc Port Access Kit 20G x 0.75in, MiniLoc Port Access Kit 22G x 1 in, MiniLoc Port Access Kit 22G x 0.75in, MiniLoc Port Access Kit 19G x 1 in with Y-Site, MiniLoc Port Access Kit 20G x 1 in with Y-Site, MiniLoc Port Access Kit 20G x 0.75in with Y-Site, MiniLoc Port Access Kit 22G x 1.5in with Y-Site, MiniLoc Port Access Kit 22G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 19G x 1.0 in with Y-Site, PowerLoc Max Port Access Kit 19G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 20G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 19G x 1.0 in , PowerLoc Max Port Access Kit 20G x 1.0 in , PowerLoc Max Port Access Kit 20G x 0.75in , PowerLoc Max Port Access Kit 22G x 1.0 in , PowerLoc Max Port Access Kit 22G x 0.75in The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.

Z-1273-2015
Recall number
Z-1273-2015
Initiated
August 08, 2014
Classification
Class II
Status
Terminated
Recalling firm
Bard Access Systems
Quantity
135,284 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.

Code information

Lot Numbers: REXE0073, REXD0494, REYF0446, REXE0074, REXE0090, REYE1239, REXD1915, REXD2151, REXD2152, REYE1275, REYF0305, REXD2142, REYE1697, REXE0082, REYE1240, REYE0972, REXE0083, REXE0072, REXE0095, REYE1276, REXE0081, REYE1267, REYE1568, REXD1616, REXE0087, REYE1232, REYE1567, REXE0092, REXE0094, REYE1585, REXD1936, reye0216, REYE1707, REYE1270, REXE0075, REYF0303, reyd1639, REXE0084, REXE0088, REYE1566, REXD1918, REYE1266, REXE0091, REYE1694, REXD1930, REYE1231, REXD2153, REXD2154, REXE0076, REYE1693 Product codes: PA-0029, PA-0029YN, PA-0030, PA-0031, PA-0031YN, PA-0032, PA-0032YN, PA-0033, PA-0033YN, PA-0034, PA-0034YN, PA-0038, PA-0038YN, 2632010, 2632034, 2632210, 2632234, 2681910, 2682010, 2682034, 2682215, 2682234, 2131910, 2131975, 2132075, 2141910, 2142010, 2142075, 2142210, 2142275

Distribution pattern

US Nationwide Distribution.

device · product 4 of 5

BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.

Z-1274-2015
Recall number
Z-1274-2015
Initiated
August 08, 2014
Classification
Class II
Status
Terminated
Recalling firm
Bard Access Systems
Quantity
4375 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.

Code information

Lot Numbers: REYE1308, REYE2224, REYD0054, REYE2225, REYE1434, REYE2226 Product codes: M120081, M120081D, M120101, M118081

Distribution pattern

US Nationwide Distribution.

device · product 5 of 5

BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.

Z-1275-2015
Recall number
Z-1275-2015
Initiated
August 08, 2014
Classification
Class II
Status
Terminated
Recalling firm
Bard Access Systems
Quantity
48 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.

Code information

Lot Numbers: 13FB8860 Product codes: CK000069

Distribution pattern

US Nationwide Distribution.